Digital apparatus and application for cancer cachexia therapy and methods of use thereof

Abstract

To provide systems and methods for cancer cachexia therapy.SOLUTION: A system may include a digital apparatus which may comprise a digital instruction generation unit configured to generate digital therapeutic modules for treating cancer cachexia, generate specified digital instructions based on the digital therapeutic modules and provide the digital instructions to a first user; and an outcome collection unit configured to collect outcomes of execution of the digital instructions by the first user.SELECTED DRAWING: Figure 3

Description

[Background technology]

[0001] This application claims the benefit of priority to U.S. Patent Application No. 63 / 029,997, filed May 26, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] Cancer cachexia is characterized by a persistent loss of skeletal muscle mass (with or without fat mass loss) that cannot be fully replaced by normal nutrition. Current treatments for cachexia include drugs aimed at slowing or halting the progression of the disorder. Treatments include, for example, orexigenic agents (i.e., appetite enhancers), corticosteroids, cannabinoids, serotonin antagonists, prokinetic agents, androgens and anabolic agents, anticytokine agents, non-steroidal anti-inflammatory and circadian rhythm modulating agents, with most treatments directed at treating the underlying or associated disease (e.g., cancer). However, such treatments (e.g., using small molecules, biologics, etc.) are sometimes used with adjustments depending on the patient's ability to tolerate treatment due to cachexia. Thus, there is a need in the art for improved treatments (e.g., digital therapeutics) for debilitating disorders such as cachexia. Summary of the Invention [Problem to be solved by the invention]

[0003] The present disclosure relates to digital therapeutics (hereinafter referred to as DTx) intended for the treatment of cancer cachexia. The present disclosure also relates to a system for integrating digital therapeutics with one or both of a healthcare provider portal and an administrative portal to treat cancer cachexia in a patient. Some embodiments of the present disclosure include inferring the mechanism of action (hereinafter referred to as MOA) of cancer cachexia, establishing therapeutic hypotheses and digital therapeutic hypotheses for inhibiting the progression of cancer cachexia, and treating cancer cachexia based on such findings. [Means for solving the problem]

[0004] In some aspects, the present disclosure provides a method of treating cancer cachexia in a subject in need thereof, the method comprising administering to the subject, via an electronic device, a voluntary skeletal muscle exercise module, a vagal nerve stimulation module, an aerobic exercise module, and a relaxation module. providing, to the subject, one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, each of the one or more first modules including one or more first tasks to be followed by the subject, wherein the electronic device (i) includes a sensor for sensing a degree of compliance by the subject with the first tasks of the one or more first modules, (ii) transfers compliance information to a server based on the degree of compliance, and (iii) receives one or more second tasks from the server based on the compliance information; and providing, to the subject, one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, wherein the one or more second modules include one or more second tasks.

[0005] In some aspects, the present disclosure provides a computing system for treating cancer cachexia in a subject in need of such treatment, the computing system including: a display configured to provide to the subject one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, each of the one or more first modules including one or more first tasks to be followed by the subject; a sensor configured to sense compliance by the subject with the tasks of the one or more first modules; a transmitter configured to transmit compliance information to a server based on the compliance; and a receiver configured to receive one or more second tasks from the server based on the compliance information; The display is further configured to provide to the subject one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module, each of the one or more second modules including one or more second tasks.

[0006] In some aspects, the disclosure provides a non-transitory computer readable medium having stored thereon software instructions for treating cancer cachexia in a subject in need of such treatment, the software instructions, when executed by a processor, causing the processor to: display, by an electronic device, to the subject, one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, each of the one or more first modules including a task to be followed by the subject; sense, by a sensor of the electronic device, a degree of compliance by the subject with the tasks of the one or more first modules; transmit, by the electronic device, compliance information to a server based on the degree of compliance; receive from the server one or more second tasks based on the compliance information; display, by the subject, one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, each of the one or more first modules including one or more second tasks.

[0007] In some aspects, the disclosure provides a system for treating cancer cachexia in a subject, the system including: a digital device configured to execute a digital application including one or more first modules for treating cancer cachexia in the subject, the digital device including a sensor for sensing the subject's compliance with a first set of challenges of the one or more first modules; a healthcare provider portal configured to provide one or more options to a healthcare provider to perform one or more actions for prescribing treatment for the subject's cancer cachexia based on information received from the digital application; and an administration portal configured to provide one or more options to an administrator of the system to perform one or more actions for managing access to the system by the healthcare provider.

[0008] In some embodiments, the digital application for treating cancer cachexia causes a processor of the digital device to: The method further includes: instructing the user to perform operations including generating a digital therapeutic module for treating cancer cachexia based on a mechanism of action and a treatment hypothesis for cancer cachexia. In some embodiments, generating the digital therapeutic module includes generating the digital therapeutic module based on a biochemical factor associated with cancer cachexia. In some embodiments, the one or more first modules include a voluntary skeletal muscle exercise module, the voluntary skeletal muscle exercise module includes one or more first tasks for increasing MGF / IGF-1 secretion in the subject. In some embodiments, the one or more first tasks include tasks for aerobic exercise, resistance exercise, and / or simultaneous exercise. In some embodiments, the one or more first modules include a vagus nerve stimulation module, the vagus nerve stimulation module includes one or more first tasks for reducing inflammation in the subject. In some embodiments, the one or more first modules include a vagus nerve stimulation module, the vagus nerve stimulation module includes at least one task selected from the group consisting of sensory stimulation tasks for sight, sound, touch, taste, and smell. In some embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for vision, where the one or more sensory stimulation tasks for vision include one or more tasks for viewing one or more pictures (defined herein to include specific photographs) to stimulate the autonomic nervous system. In some embodiments, the electronic device receives and displays the pictures. In some embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for hearing, where the one or more sensory stimulation tasks for hearing include one or more tasks for listening to one or more sounds to induce fear or relaxation. In some embodiments, the electronic device receives and plays sounds. In some embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, where the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing, breathing rate control, cooling massage, coughing, and skin massage.In some embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing. In some embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for taste, the one or more sensory stimulation tasks for taste include one or more tasks encouraging eating food to stimulate the subject's digestive glands. In some embodiments, the electronic device receives and displays information related to food. In some embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for smell, the one or more sensory stimulation tasks for smell include one or more tasks for stimulating / stimulating or relaxing the digestive glands. In some embodiments, the electronic device is configured to emit a scent for aromatherapy. In some embodiments, the one or more first modules include an aerobic exercise module, the aerobic exercise module includes one or more first tasks for increasing adiponectin secretion in the subject. In some embodiments, the one or more first tasks include one or more tasks for walking, cycling, aerobic dancing, and / or swimming. In some embodiments, the one or more first modules include a relaxation module, and the relaxation module includes one or more first tasks for increasing adiponectin secretion in the subject. In some embodiments, the one or more first tasks include one or more meditation tasks. In some embodiments, the one or more first tasks include one or more auditory tasks for listening to relaxing sounds. In some embodiments, the device receives and plays relaxing sounds. In some embodiments, the subject is an early stage cancer patient. In some embodiments, the subject has a cancer mass having a diameter of 3 cm or less. In some embodiments, the subject is a terminal cancer patient, and the system excludes providing a voluntary skeletal muscle movement module. In some embodiments, the subject has a cancer mass having a diameter of more than 3 cm, and the system excludes providing a voluntary skeletal muscle movement module.In some embodiments, the subject has intermediate muscle atrophy, and the one or more first modules comprise a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module. In some embodiments, the subject has intermediate muscle atrophy, and the one or more first modules comprise a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module. In some embodiments, the subject has intermediate muscle atrophy (as defined herein, intermediate muscle atrophy is still able to walk). In some embodiments, the subject has severe muscle atrophy (as defined herein, severe muscle atrophy is not able to walk), and the system excludes providing a voluntary skeletal muscle movement module and further excludes providing an aerobic exercise module. In some embodiments, the one or more first modules comprise a vagus nerve stimulation module and a relaxation module. In some embodiments, the digital application transmits data to a server, and the server receives one or more second tasks from an external reviewer. In some embodiments, the external reviewer includes a health professional. In some embodiments, the external reviewer includes an artificial intelligence (AI). In some embodiments, the sensor includes one or more of a camera, an accelerometer, a magnetometer, a light sensor, a microphone, a proximity sensor, a touch sensor, a gyroscope, a Global Positioning System (GPS) sensor, an ambient light sensor, a fingerprint sensor, a pedometer, a heart rate sensor, and a thermometer. In some embodiments, the sensor includes a touch sensor, and the subject uses the touch sensor to provide the adherence information to the electronic device. In some embodiments, the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing a subject, viewing or editing personal information about a subject, viewing adherence information about a subject, viewing a subject's results for one or more at least partially completed digital therapeutic modules, prescribing one or more digital therapeutic modules to a subject, changing a prescription for one or more digital therapeutic modules, and communicating with a subject.In some embodiments, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's guardian's email, a contact phone number for the subject, a prescription for the subject, and one or more notes made by a healthcare provider for the subject. In some embodiments, the personal information includes a prescription for the subject, the prescription for the subject including one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, a number of scheduled or prescribed digital therapeutic modules performed by the subject, and a number of scheduled or prescribed digital therapeutic modules performed by the subject per day. In some embodiments, the one or more options include viewing adherence information for the subject, the adherence information for the subject including one or more of a number of scheduled or prescribed digital therapeutic modules completed by the subject, and a calendar identifying one or more dates on which the subject has completed, partially completed, or not completed one or more scheduled or prescribed digital therapeutic modules. In some embodiments, the one or more options include viewing subject outcomes, where the subject outcomes for one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of: a time the subject started a scheduled or prescribed digital therapeutic module, a time the subject finished a scheduled or prescribed digital therapeutic module, an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI). In some embodiments, the one or more options provided to an administrator of the system are selected from the group consisting of adding or removing healthcare providers, viewing or editing personal information about healthcare providers, viewing or editing de-identified information about the subject, viewing compliance information about the subject, viewing subject outcomes for one or more at least partially completed digital therapeutic modules, and communicating with healthcare providers.In some embodiments, the one or more options include viewing or editing personal information, where the health care provider's personal information includes one or more selected from the group consisting of an identification number for the health care provider, the health care provider's name, the health care provider's email, and a contact phone number for the health care provider. In some embodiments, the one or more options include viewing or editing de-identified information for the subject, where the de-identified information for the subject includes one or more selected from the group consisting of an identification number for the subject and a health care provider for the subject. In some embodiments, the one or more options include viewing adherence information for the subject, where the subject's adherence information includes one or more of a number of scheduled or prescribed digital therapeutic modules completed by the subject, and a calendar identifying one or more dates on which the subject has completed, partially completed, or not completed one or more scheduled or prescribed digital therapeutic modules. In some embodiments, the one or more options include viewing the subject's results, and the subject's results for the one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of a time when the subject started the scheduled or prescribed digital therapeutic module, a time when the subject finished the scheduled or prescribed digital therapeutic module, an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI). In some embodiments, the digital application further includes a push alarm for one or more of reminding the subject to complete the digital therapeutic module. In some embodiments, the digital device includes a digital challenge generator configured to generate a digital therapeutic module for treating cancer cachexia, generate a digital challenge based on the digital therapeutic module, and provide the digital challenge to the subject, and in some embodiments, a result collector configured to collect results of the subject's execution of the digital challenge. In some embodiments, the digital challenge generator generates the digital therapeutic module based on biochemical factors associated with the onset of cancer cachexia.In some embodiments, the biochemical factors include insulin-like growth factor 1 (IGF1) and hypoxia-inducible factor 1 (HIF1). In some embodiments, the digital task generator generates the digital therapeutic module based on input from a healthcare provider. In some embodiments, the digital task generator generates the digital therapeutic module based on information received from the subject. In some embodiments, the information received from the subject includes information about the subject's basal factors, medical information, and digital therapeutic comprehension ability (. The baseline factors include at least one of the following: subject's activity, heart rate, sleep, and diet (including nutrients and calories); the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerability, genetic susceptibility; and the digital therapeutics literacy includes the subject's accessibility and technology adoption to digital therapeutics and devices. In some embodiments, the digital challenge generator generates a digital therapeutics module that matches virtual parameters corresponding to a therapeutic hypothesis and mechanism of action for cancer cachexia. In some embodiments, the virtual parameters are inferred in relation to the subject's environment, behavior, emotions, and cognition. In some embodiments, the result collector collects results of the execution of the digital challenge by monitoring the subject's compliance with the digital challenge or by allowing the subject to directly input the subject's compliance with the digital challenge. In some embodiments, the generation of digital tasks in the digital task generator and the collection of results of the subject's execution of the digital tasks in the result collector are performed multiple times in multiple feedback loops, and the digital task generator generates the subject's digital tasks for such cycle based on the subject's digital tasks in previous cycles and execution result data for the subject's digital tasks in previous cycles collected in the result collector. [Brief description of the drawings]

[0009] The above and other objects, features and advantages of the present disclosure will become more apparent to those of ordinary skill in the art from the detailed description of exemplary embodiments thereof, taken in conjunction with the accompanying drawings.

[0010] [Figure 1] Illustrates muscle wasting associated with cancer cachexia. [Diagram 2] Illustrates various biochemical pathways and physiological symptoms associated with cancer cachexia, as well as applications and associated effects of certain embodiments of the present disclosure. [Diagram 3] FIG. 1 is a block diagram illustrating an exemplary configuration of a digital device for treating cancer cachexia according to one embodiment of the present disclosure. [Figure 4] FIG. 1 illustrates an exemplary input and output loop of a digital application for treating cancer cachexia according to an embodiment of the present disclosure. [Diagram 5] FIG. 1 illustrates exemplary background factors supporting a digital device and application for cancer cachexia treatment according to an embodiment of the present disclosure. [Figure 6] 1A and 1B illustrate an exemplary method of assigning a patient-tailored digital prescription using digital devices and applications for cancer cachexia treatment according to one embodiment of the present disclosure. [Figure 7] 1 is a flowchart illustrating an exemplary operation of a digital application for cancer cachexia treatment according to one embodiment of the present disclosure. [Figure 8] FIG. 1 illustrates an exemplary hardware configuration of a digital device for cancer cachexia treatment according to one embodiment of the present disclosure. [Figure 9]1 is a flowchart illustrating an exemplary system for treating cancer cachexia, the system including an administrative portal (e.g., administrator web), a healthcare provider portal (e.g., physician web) and a digital device configured to run a digital application (e.g., an application or "app") for treating cancer cachexia in a subject. [Figure 10A] 1 is a flowchart illustrating the flow of use of an exemplary digital application of the present disclosure. [Figure 10B] 1 is a flowchart illustrating the flow of use of an exemplary digital application of the present disclosure. [Figure 11] 1 is a flowchart illustrating an exemplary execution flow for login verification during a splash process upon initiation of a digital application of the present disclosure. [Figure 12] 1 is a flow chart illustrating the structure of an exemplary patient portal of the digital application of the present disclosure. [Figure 13] 13 is a flow chart illustrating an example patient portal external activity usage flow of the digital application of the present disclosure. [Figure 14] 1 is a flow chart illustrating an example internal activity usage flow of a digital application of the present disclosure. [Figure 15] 1 is a flow chart illustrating an example physician portal structure and an administration portal structure of the digital application of the present disclosure. [Figure 16] 1 is a flowchart illustrating an exemplary execution flow for an administrative portal in the system of the present disclosure.

[0011] Although the above-identified drawings set forth the presently disclosed embodiments, other embodiments are contemplated, as noted in the discussion. This disclosure presents exemplary embodiments by way of representation, not limitation. Numerous other modifications and embodiments can be devised by those of ordinary skill in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Hereinafter, exemplary embodiments of the present disclosure will be described in detail. However, the present disclosure is not limited to the embodiments disclosed below, and may be realized in various forms. The following embodiments are provided to enable a person skilled in the art to realize and implement the embodiments of the present disclosure.

[0013] definition Terms such as first, second, etc. may be used to describe various elements, but these elements are not limited by such terms. Such terms are only used to distinguish one element from another. For example, a first element may be referred to as a second component, and similarly, the second element may be referred to as the first element, without departing from the scope of the exemplary embodiments. The term "and / or" includes any and all combinations of one or more of the associated listed items.

[0014] The terms used in this application are merely used to describe certain embodiments and are not intended to limit the exemplary embodiments. The singular forms "a", "an" and "the" are intended to include the plural forms unless the context clearly indicates otherwise. It can be further understood that the terms "comprises", "comprising", "includes" and / or "including", when used in this application, specify the presence of stated features, integers, steps, operations, elements, components and / or groups thereof, but do not exclude the presence or addition of one or more different features, integers, steps, operations, elements, components and / or groups thereof.

[0015] As used herein, the term "about" refers to a particular numerical value that is within an acceptable error range as determined by one of ordinary skill in the art, which generally depends in part on how the numerical value is measured or determined, i.e., the limitations of the measurement system. For example, "about" can mean a range of ±20%, ±10%, or ±5% of the given numerical value.

[0016] As used herein, "muscle atrophy" may refer to a disease in which muscles of the body (e.g., legs and arms) gradually and sometimes symmetrically atrophy. Muscle atrophy may be associated with the development of cancer, aging, kidney disease, genetic disorders, and various chronic diseases.

[0017] As used herein, the term "cancer cachexia" may refer to a condition characterized by persistent loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully replaced by normal nutrition.

[0018] overview Hereinafter, exemplary embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. To facilitate understanding of the present disclosure, similar numbers refer to similar elements throughout the description of the drawings, and descriptions of the same elements will not be repeated.

[0019] New drug development begins by identifying internal demand on-site, proposing the mechanism of action based on expert review and meta-analysis of the corresponding disease, and inferring a treatment hypothesis based on expert review and meta-analysis. After a library of drugs with expected therapeutic effects is prepared based on the treatment hypothesis, candidate substances are searched for by screening, and the corresponding candidate substances undergo optimization and preclinical testing to confirm their efficacy and safety from the preclinical stage, and thus the candidate substances are determined as the final candidate drugs. In order to mass-produce the corresponding candidate drugs, a CMC (chemistry, manufacturing, and control) process is also established, and clinical trials are conducted on the corresponding candidate drugs to verify the mechanism of action and treatment hypothesis of the candidate drugs, thereby ensuring the clinical efficacy and safety of the candidate drugs.

[0020] From the perspective of such patents, drug targeting and signaling, which are upstream of new drug development, have various uncertainties. In many cases, drug targeting and signaling require a methodology of synthesizing results reported in the technical field and interpreting the results, so it may be difficult to guarantee the novelty of the disclosure. Conversely, the disclosure of a drug that can regulate drug targeting and signaling for disease treatment requires the highest level of ingenuity, except for some antibody or nucleic acid (DNA, RNA) therapeutic fields, despite the development of research methodologies for the research and development of numerous new drugs. As a result, the molecular structure of a drug is the most important element that constitutes the most powerful substance patent in the new drug field.

[0021] Unlike drugs, whose rights are strongly protected by such substance patents, digital therapy is essentially realized using software. Due to the characteristics of digital therapy, the rational design of digital therapy for the corresponding disease and the software realization of digital therapy based on the rational design can be considered as an improved process of the disclosure protected by a patent, considering the clinical validation and approval process as a treatment.

[0022] That is, the core of the digital therapy as disclosed herein is the rational design of the digital therapy suitable for the treatment of the corresponding disease and the development of specific software that can clinically verify the digital therapy based on the rational design. Hereinafter, the digital device and application for the treatment of cancer cachexia according to the present disclosure realized in this manner will be described in detail.

[0023] FIG. 1 illustrates the progression of muscle atrophy, one aspect of cancer cachexia (another aspect is cancer). As used herein, "muscle atrophy" may refer to a disease in which muscles of the body (e.g., legs and arms) gradually atrophy, sometimes symmetrically. Muscle atrophy may be associated with cancer, aging, kidney disease, genetic disease, and the development of various chronic diseases. Muscle atrophy is typified by amyotrophic lateral sclerosis (Lou Gehrig's disease), spinal progressive muscular atrophy, and the like. A normal or healthy person (far right) is capable of movement. Muscle wasting or atrophy may lead to intermediate muscle atrophy, where physical movement is still possible. Intermediate muscle atrophy may be characterized by reduced motor function, where patients can still walk, although not as well as healthy individuals (e.g., patients with intermediate muscle atrophy may have a non-normal gait, a hunched and / or stiff posture, and the like). Additional muscle wasting may lead to severe muscle atrophy, where physical movement is no longer possible. Severe muscle atrophy may be characterized by reduced or complete loss of motor function, such as the inability to walk. In general, the stage of muscle atrophy may be determined or classified by muscle volume and / or motor ability. Similarly, myogenesis may restore muscle function. The disclosed method and system may promote myogenesis from patients suffering from severe and intermediate muscle atrophy to restore normal muscle function. In the case of patients suffering from muscle atrophy, the disclosed method and system may help promote myogenesis, reducing muscle atrophy and allowing patients to tolerate, for example, cancer treatments that may otherwise be impossible for patients suffering from severe muscle atrophy.

[0024] FIG. 2 illustrates various exemplary biochemical pathways and physiological symptoms associated with cancer cachexia, as well as exemplary applications and associated effects of certain embodiments of the present disclosure. Cachexia can be characterized by acquired accelerated muscle loss due to the underlying disease. When cachexia appears in patients with cancer, the condition can be referred to as "cancer cachexia". Cancer cachexia affects most patients with advanced cancer and is associated with treatment resistance, response to therapeutic agents, reduced quality of life and survival. Cancer cachexia is a multifactorial condition characterized by persistent loss of skeletal muscle mass with or without loss of fat mass that cannot be fully restored with regular nutritional support and gradually leads to impaired function. Skeletal muscle loss can be the most important event in cancer cachexia.

[0025] As mentioned above, one objective of the disclosed method and system is to at least partially reduce muscle atrophy so that patients can tolerate cancer treatment. Muscle atrophy can be caused by increased myostatin levels, which promote protein degradation. In one aspect, the disclosed method and system can increase insulin-like growth factor 1 (IFG1) and / or splice variant of IGF-1, referred to as mechano growth factor (MGF) levels (IGF1 / MGF levels), for example, using voluntary skeletal muscle exercise modules and / or digital challenges to a patient's diet that can (i) suppress myostatin and prevent / prevent muscle atrophy associated with protein degradation, or (ii) activate insulin receptor substrate 1 (IRS1)-PI3K-AKT signaling and AKT to promote protein synthesis. Muscle atrophy may also be due to activation of the NF-kB pathway (e.g., by release of multiorgan inflammatory factors and / or cachectic inflammatory cytokines TNF-α / IL-1) that promotes protein degradation. In one embodiment, the disclosed method and system inhibits activation of the NF-kB pathway by promoting adiponectin secretion, for example, by meditation and / or aerobic exercise. In another embodiment, the disclosed method and system inhibits activation of the NF-kB pathway by inhibiting cachectic inflammatory cytokines TNF-α / IL-1 by vagus nerve stimulation.

[0026] Besides cachexia, cancer is another form of cancer cachexia. For early cancer patients, stimulating IGF1 secretion, for example, by physical exercise, can be helpful in treating cancer cachexia. However, for terminal cancer patients, the above strategy may have the side effect of promoting HIF1 and accelerating cancer progression. Therefore, for terminal cancer, cancer cachexia treatments can exclude treatments that stimulate IGF1 secretion, such as physical exercise. Therefore, depending on the progression of cancer, the prescription of modules assigned to each patient may be different. Therefore, early external activities for early cancer patients are different from late external activities for terminal cancer patients as described in this application.

[0027] In some embodiments, the later external activity includes touching the screen with a finger or heel, and taking a deep breath. The touch can be monitored by a touch sensor, an acceleration sensor, and / or a gyro sensor. In further embodiments, the later external activity includes lifting the head while lying down, lifting a hand or a foot while lying down, which can be monitored by an acceleration sensor, a gyro sensor, or a touch sensor. In further embodiments, the later external activity includes taking a phone call while lying down, turning the head while lying down. The taking can be monitored by a touch sensor or gesture recognition. The turning the head can be monitored by face recognition.

[0028] Below, the present disclosure describes a digital device and application for inhibiting the progression and treating cancer cachexia.

[0029] Generally speaking, disease treatment is performed by analyzing a particular disease in terms of pathophysiological functions and predisposing factors to determine the onset, progression and end point of the disease. Also, disease symptoms are defined by characterizing the corresponding disease and statistically analyzing the disease. Also, physiological factors, especially biochemical factors, of the patient corresponding to the verified symptoms are analyzed, and the patient's biochemical factors are restricted to a narrow range related to the disease to infer the mechanism of action.

[0030] Next, a therapeutic hypothesis is inferred that the corresponding disease is treated by adjusting the action and environment directly related to the regulation of the corresponding biochemical factor associated with the disease. In order to realize such a therapeutic hypothesis as a digital treatment, a digital treatment hypothesis is proposed to achieve a therapeutic effect by repeating digital tasks and execution related to "patient behavior control / environmental regulation of biochemical factors". The digital treatment hypothesis of the present disclosure is realized as a digital device, and the application is realized as an application and digital device configured to present changes in the patient's behavior and the patient's participation in the form of a specific task, and to collect and analyze the execution of the specific task.

[0031] 3 is a block diagram illustrating the configuration of a digital device for cancer cachexia treatment according to an embodiment of the present disclosure. Referring to FIG. 3, a digital system 000 for cancer cachexia treatment according to an embodiment of the present disclosure may include a digital task generator 010, a sensing data collector 020, a performance input unit 030, a result analyzer 040, a database 050, and a security unit 060.

[0032] Based on the mechanism of action of cancer cachexia and the treatment hypothesis and digital treatment hypothesis for cancer cachexia, the doctor (second user) can prescribe a digital treatment for the corresponding patient, which is realized in a digital device and an application for cancer cachexia treatment. In this case, the digital task generator 010 is a device configured to provide the patient with a prescription for a digital treatment as a specific behavioral task that the patient can perform based on the interaction of biochemical factors for cancer cachexia and the patient's behavior. For example, the biochemical factors can include IGF1, HIF1, etc., but the present disclosure is not limited thereto. For example, all types of biochemical factors that can cause cancer cachexia can be considered.

[0033] The digital task generator 010 may generate a digital task based on an input from a doctor. In this case, the digital task generator 010 may generate a digital task based on information collected by a doctor when diagnosing a patient. The digital task generator 010 may also generate a digital task based on information received from a patient. For example, the information received from a patient may include the patient's baseline factors, medical information, and digital therapeutic literacy. In this case, the baseline factors may include the patient's activity level, heart rate, sleep, diet (nutrition and calories), etc. The medical information may include the patient's electronic medical record (EMR), family history, genetic vulnerability, genetic susceptibility, etc. The digital therapeutic literacy may include the patient's accessibility and receptive attitude to digital therapeutic tasks and devices, etc.

[0034] The digital problem generator 010 can reflect the mechanism of action and treatment hypotheses for cancer cachexia to generate digital modules using virtual parameters, where the virtual parameters can be inferred in terms of patient behavior.

[0035] The digital task generator 010 generates specially designed digital tasks and provides the tasks to the patient so that the patient can have a therapeutic effect. For example, the digital task generator 010 can generate specific digital tasks for each of the digital therapeutic modules.

[0036] The sensing data collecting unit 020 and the performance input unit 030 can collect the results of the patient's performance of the digital task provided from the digital task generating unit 010. Specifically, the sensing data collecting unit 020 configured to sense the patient's compliance with the digital task and the performance input unit 030 configured to allow the patient to directly input the results of the performance of the digital task are included, and serve to output the results of the patient's performance of the digital task.

[0037] The result analysis unit 040 can collect the patient's behavioral compliance or participation for a predetermined period of time and report the patient's behavioral compliance or participation to an external system. Therefore, a doctor can continue to monitor the progress of the digital task through the application even if the patient does not visit the hospital in person.

[0038] The database 050 can store the mechanism of action of cancer cachexia, the treatment hypothesis regarding cancer cachexia, the digital assignment provided to the user, and the user's performance result data. Figure 3 illustrates that the database 050 is included in the digital device 000 for cancer cachexia treatment. However, the database 050 can be provided to an external server.

[0039] Meanwhile, a series of loops including inputting a digital task in the digital task generating unit 010, outputting the digital task execution results of the patient in the sensing data collecting unit 020 / performance input unit 030, and evaluating the execution results in the result analyzing unit 040 may be repeated multiple times. In this case, the digital task generating unit 010 may generate a digital task tailored to the patient for the current cycle by reflecting the digital task, output value, and evaluation of the patient provided in the previous cycle.

[0040] As described above, according to the digital therapeutic agent device for inhibiting the progression and treating cancer cachexia disclosed herein, a cancer cachexia therapeutic agent whose reliability can be guaranteed can be produced by taking into account biochemical factors for cancer cachexia, inferring the mechanism of action of cancer cachexia and a treatment hypothesis and digital treatment hypothesis regarding cancer cachexia, presenting digital tasks for cancer cachexia treatment based on the mechanism of action and treatment hypothesis, and analyzing and collecting the execution of specific tasks.

[0041] FIG. 4 is a diagram illustrating the input and output loops of a digital application for cancer cachexia treatment according to one embodiment of the present disclosure.

[0042] Referring to FIG. 4, a digital application for cancer cachexia treatment according to one embodiment of the present disclosure can input a corresponding digital prescription for a patient in the form of an assignment and output the execution result of the corresponding digital assignment.

[0043] The digital challenges provided to the patient may include specific behavioral challenges for behavior, etc. As illustrated in Figure 4, the digital challenges may include voluntary skeletal muscle exercise, vagus nerve stimulation, aerobic exercise, relaxation, etc. However, the digital challenges are provided merely in an exemplary manner and are not intended to limit the digital challenges according to the present disclosure.

[0044] The results of a patient's digital task execution consist of 1) login / logout information for the task and execution, 2) compliance information sensed as passive data such as voluntary skeletal muscle movement, stress-related heart rate, and oxygen saturation changes, and 3) directly entered information regarding the patient's execution results.

[0045] This is achieved by implementing multiple iterations of the single feedback loop of FIG. 4 referred to above, illustrating the inhibition of progression and treatment of cancer cachexia by regulating biochemical factors.

[0046] The inhibitory and therapeutic effects on the progression of cancer cachexia can be more effectively achieved by progressive improvement of the task-action cycle in a feedback loop, compared with a simply repeated task-action cycle during the course of the corresponding treatment.

[0047] For example, the digital task and execution results of the first cycle are provided as input and output values ​​in a single loop, but a new digital task can be generated by reflecting the input and output values ​​generated in this loop using a feedback process of the loop to adjust the input for the next loop when the feedback loop is executed N times. Such a feedback loop can be performed iteratively to infer a digital task tailored to the patient and maximize the treatment effect.

[0048] In this way, in the digital device and application for cancer cachexia treatment according to one embodiment of the present disclosure, the data on the patient's digital task and task execution results provided in the previous cycle (e.g., the N-1th cycle) can be used to calculate the patient's digital task and execution results in this cycle (e.g., the Nth cycle). That is, the digital task of the next loop can be generated based on the patient's digital task and the execution results of the digital task calculated in the previous loop. In this case, various algorithms and statistical models can be used for the feedback process as necessary.

[0049] As described above, a digital device and application for cancer cachexia treatment according to one embodiment of the present disclosure allows for optimization of a patient-specific digital challenge via a rapid feedback loop.

[0050] FIG. 5 is a diagram illustrating background factors supporting a digital device and application for cancer cachexia treatment according to one embodiment of the present disclosure.

[0051] Referring to FIG. 5, both contextual factors can be considered in designing a digital device and application module for cancer cachexia treatment according to one embodiment of the present disclosure.

[0052] In such a case, the background factors are necessary elements for correcting the clinical trial results during the verification of the clinical effect of the digital cancer cachexia treatment according to the present disclosure. Specifically, in the background factors illustrated in Figure 5, the basic factors can include activity, heart rate, sleep, diet (nutrition and calories), etc., the medical information can include EMR, family history, genetic vulnerability, susceptibility, etc., which may have been created when the patient visited the hospital, and the digital therapeutic agent comprehension ability can include the patient's accessibility and acceptance attitude to the digital therapeutic agent task and device.

[0053] FIG. 6 is a diagram illustrating a method for assigning a patient-tailored digital prescription using digital devices and applications for cancer cachexia treatment according to one embodiment of the present disclosure.

[0054] FIG. 6A illustrates a prescription procedure for a physician's routine medical status review of a patient, and FIG. 6B illustrates a method that enables a physician to assign a tailored digital prescription to a patient based on an analysis of multiple digital tasks and the results of the execution of the digital tasks.

[0055] In this manner, when the digital device and application for cancer cachexia treatment according to one embodiment of the present disclosure is used, as shown in FIG. 6(B), the physician can review the patient's tasks and performance results during a given period of time and adjust the tasks for each module in a manner tailored to the type of module and patient for cancer cachexia treatment.

[0056] FIG. 7 is a flow chart illustrating operations in a digital application for cancer cachexia treatment according to one embodiment of the present disclosure.

[0057] 7, a digital application for cancer cachexia treatment according to an embodiment of the present disclosure may first generate a digital therapeutic agent module for cancer cachexia treatment based on the mechanism of action and treatment hypothesis for cancer cachexia (S810). In this case, in S810, a digital therapeutic agent module may be generated based on biochemical factors for cancer cachexia (e.g., IGF1, HIF1, etc.).

[0058] Meanwhile, in S810, a digital therapeutic agent module may be generated based on input from a physician. In this case, the digital therapeutic agent module may be generated based on information collected by a physician when diagnosing a patient and prescription results recorded based on the information. Also, in S810, a digital therapeutic agent module may be generated based on information received from a patient (e.g., baseline factors, medical information, digital therapeutic agent comprehension ability, etc.).

[0059] A specific digital challenge can then be generated based on the digital therapeutic module in S820. S820 can apply virtual parameters for the patient's environment, behavior, emotions, and cognition to the treatment hypotheses and mechanisms of action for cancer cachexia to generate the digital therapeutic module.

[0060] In this case, a digital task for at least one of the voluntary skeletal muscle exercise, vagus nerve stimulation, aerobic exercise, and relaxation modules can be generated. The digital task can then be provided to the patient (S830). In this case, the digital task can be provided in the form of a digital task related to behavior, such as voluntary skeletal muscle exercise, in which the patient's compliance with the task can be monitored using a sensor, or in the form of a digital task in which the patient can directly input the execution result.

[0061] After the patient performs the presented digital task, the patient's performance results of the digital task may be collected (S840). At S840, the performance results of the digital task may be collected by monitoring the patient's compliance with the digital task as described above or by allowing the patient to input the performance results of the digital task.

[0062] In some embodiments, the patient or caregiver enters sleep times, blood glucose levels, food intake or meal information, appetite stimulant or other medication intake information, albumin levels, early external activity, late external activity and / or internal activity information daily, and all or part of the information can be monitored by a physician, for example on his or her web.

[0063] Meanwhile, a digital application for cancer cachexia treatment according to an embodiment of the present disclosure may perform operations multiple times, where the operations include generating a digital challenge and collecting patient execution results of the digital challenge, where generating the digital challenge may include generating a patient digital challenge for such cycle based on the patient's digital challenge provided in a previous cycle and the patient's execution result data for the collected digital challenge provided in the previous cycle.

[0064] As described above, according to a digital application for treating cancer cachexia according to one embodiment of the present disclosure, inhibition of progression of cancer cachexia and reliability of treatment can be ensured by taking into account biochemical factors for cancer cachexia, inferring a mechanism of action and a treatment hypothesis for cancer cachexia, presenting a digital task to the patient based on the mechanism of action and a treatment hypothesis for cancer cachexia, and collecting and analyzing the results of the digital task.

[0065] Although the digital device and application for cancer cachexia treatment according to one embodiment of the present disclosure are described in terms of a cancer cachexia treatment, the present disclosure is not limited thereto. For diseases other than cancer cachexia, the digital treatment can be performed in substantially the same manner as described above.

[0066] FIG. 8 is a diagram illustrating the hardware configuration of a digital device for cancer cachexia treatment according to one embodiment of the present disclosure.

[0067] Referring to FIG. 8 , hardware 600 of a digital device for cancer cachexia treatment according to one embodiment of the present disclosure may include a CPU 610 , a memory 620 , an input / output I / F 630 and a communication I / F 640 .

[0068] The CPU 610 may be a processor configured to execute a digital program for cancer cachexia treatment stored in the memory 620, process various data for the digital cancer cachexia treatment, and perform functions related to the digital cancer cachexia treatment agent. That is, the CPU 610 may serve to execute a digital program for cancer cachexia treatment stored in the memory 620 and perform functions related to each of the components illustrated in FIG.

[0069] The memory 620 may have a digital program for cancer cachexia treatment stored therein, and may also include data used for the digital cancer cachexia treatment agent included in the database 050 mentioned above, such as the patient's digital assignments and assignment execution results, the patient's medical information, etc.

[0070] Multiple such memories 620 can be provided as needed. The memory 620 can be a volatile memory or a non-volatile memory. If the memory 620 is a volatile memory, a RAM, a DRAM, a SRAM, etc. can be used as the memory 620. If the memory 620 is a non-volatile memory, a ROM, a PROM, an EAROM, an EPROM, an EEPROM, a flash memory, etc. can be used as the memory 620. The examples of memory 620 listed above are provided by way of example only and are not intended to limit the present disclosure.

[0071] The input / output I / F 630 may provide an interface through which input devices (not shown) such as a keyboard, mouse, touch panel, etc., and output devices such as a display (not shown) may transmit and receive data to the CPU 610 (e.g., wirelessly or via a hard line).

[0072] The communications I / F 640 is configured to transfer and receive various types of data to / from a server and can be one of a variety of devices capable of supporting wired or wireless communication. For example, the types of data related to the digital behavior-based therapeutic agents mentioned above can be received from a separately available external server via the communications I / F 640.

[0073] As described above, a computer program according to one embodiment of the present disclosure can be realized, for example, as a module configured to execute each functional block illustrated in FIG. 3, by being recorded in memory 620 and processed by CPU 610.

[0074] According to the digital device and application for treating, ameliorating or preventing cancer cachexia disclosed herein, a reliable digital device and application can be provided that can take into account the mechanism of action of cancer cachexia and biochemical factors for the progression of cancer cachexia, infer a treatment hypothesis and a digital treatment hypothesis regarding cancer cachexia, present a digital task to a patient, and collect and analyze the results of the execution of the digital task to suppress and treat the progression of cancer cachexia.

[0075] In certain embodiments, the present disclosure provides a method for treating, ameliorating or preventing cancer cachexia in a subject in need of such treatment, the method comprising: providing, by an electronic device to the subject, one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module and a relaxation module, each of the one or more first modules including one or more first tasks to be followed by the subject, the electronic device (i) including a sensor for sensing a degree of compliance by the subject with a first task of the one or more first modules, (ii) transmitting compliance information to a server based on the degree of compliance, and (iii) receiving one or more second tasks from the server based on the compliance information; and providing, by the electronic device to the subject, one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module and a relaxation module, the one or more second modules including one or more second tasks.

[0076] In certain embodiments, the subject is diagnosed with cancer. In certain embodiments, the subject has cancer, and the subject suffers from cancer cachexia. The subject can be a cancer patient, a patient at risk of cancer, or a patient with a family or personal history of cancer. In some cases, the patient is at a certain stage of cancer treatment. In certain embodiments, the subject has cancer, and the cancer is an early stage cancer. In certain embodiments, a subject suffering from early stage cancer is a subject with a cancerous mass having a diameter of 0.1 centimeter (cm) or less, 0.5 cm or less, 2 cm or less, 3 cm or less, 4 cm or less, or 5 cm or less. In certain embodiments, the subject has cancer, and the cancer is a terminal cancer. In certain embodiments, a subject suffering from terminal cancer is a subject with a cancerous mass having a diameter of 0.1 centimeter (cm) or more, 0.5 cm or more, 1 cm or more, 2 cm or more, 3 cm or more, 4 cm or more, or 5 cm or more. Generally, a patient's cancer stage can be determined or classified based on HIF-1α expression levels (eg, in the blood), hypoxia, and / or the size of the subject's cancer mass.

[0077] The cancer patient may have any type of cancer. Examples of cancer include adrenal gland cancer, anal cancer, basal cell carcinoma, bile duct cancer, bladder cancer, blood cancer, bone cancer, brain cancer, breast cancer, bronchial cancer, cardiovascular cancer, cervical cancer, colon cancer, colorectal cancer, digestive system cancer, endocrine system cancer, endometrial cancer, esophageal cancer, eye cancer, gallbladder cancer, gastrointestinal tract tumors, kidney cancer, hematopoietic malignancies, laryngeal cancer, leukemia, liver cancer, lung cancer, lymphoma, melanoma, mesothelioma, muscle cancer, myelodysplastic syndrome (MDS), and other cancers. The cancers may include, but are not limited to, myeloma, cancer of the nasal cavity, cancer of the nasopharynx, cancer of the nervous system, cancer of the lymphatic system, cancer of the oral cavity, cancer of the oropharynx, osteosarcoma, Kaposi's sarcoma, ovarian cancer, pancreatic cancer, cancer of the penis, pituitary tumor, prostate cancer, rectal cancer, cancer of the renal pelvis, cancer of the reproductive system, cancer of the respiratory tract, sarcoma, salivary gland cancer, cancer of the skeletal system, skin cancer, cancer of the small intestine, cancer of the stomach, cancer of the testis, cancer of the larynx, cancer of the thymus, cancer of the thyroid gland, tumor, cancer of the urinary system, cancer of the uterus, cancer of the vagina, or cancer of the vulva. The term "lymphoma" may refer to any type of lymphoma, including B-cell lymphoma (e.g., diffuse large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, mantle cell lymphoma, marginal zone B-cell lymphoma, Burkitt's lymphoma, lymphoplasmacytic lymphoma, hairy cell leukemia, or primary central nervous system lymphoma) or T-cell lymphoma (e.g., precursor T-lymphoblastic lymphoma, or peripheral T-cell lymphoma). The term "leukemia" may refer to any type of leukemia, including acute leukemia or chronic leukemia. Types of leukemia include acute myeloid leukemia, chronic myeloid leukemia, acute lymphocytic leukemia, acute anaplastic leukemia, or chronic lymphocytic leukemia. In some cases, a cancer patient does not have a specific type of cancer. For example, in some cases, a patient can have a cancer that is not breast cancer.

[0078] Examples of cancers can include cancers that cause solid tumors as well as cancers that do not cause solid tumors, and any cancer referred to in this application can be a primary cancer (e.g., a cancer named after the part of the body where it first began to grow) or a secondary or metastatic cancer (e.g., a cancer that originated from another part of the body).

[0079] In some embodiments, the subject may be at risk for cancer and may be at risk due to certain conditions, such as pre-cancerous conditions. Pre-cancerous conditions include, but are not limited to, actinic keratosis, Barrett's esophagus, atrophic gastritis, ductal carcinoma in situ, congenital dyskeratosis, cytopenic dysphagia, lichen planus, oral submucous fibrosis, solar elastosis, cervical dysplasia, leukoplakia, and erythema. In some cases, the patient may be at risk for cancer due to cell or tissue dysplasia (e.g., abnormal changes in cell number, cell shape, cell size, or cell pigmentation).

[0080] In certain embodiments, the one or more first modules include a voluntary skeletal muscle movement module. In certain embodiments, the voluntary skeletal muscle movement module includes one or more first tasks for increasing MGF / IGF-1 secretion in the subject.

[0081] In certain embodiments, the one or more first tasks include tasks for aerobic exercise, resistance exercise and / or simultaneous exercise. Physical exercise (e.g., cardiovascular exercise) can promote IGF-1 production, which can (i) suppress myostatin and prevent / prevent muscle atrophy associated with protein degradation, or (ii) activate insulin receptor substrate 1 (IRS1)-PI3K-AKT signaling and AKT to promote protein synthesis. The module that includes physical exercise can include, for example, 20 minutes of high-intensity exercise and 40 minutes of rest or low-intensity exercise (e.g., a module that mimics low mountain climbing, walking, etc.) under conditions that the patient can tolerate. This module can be repeated daily, and the effect can be observed after 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months or 1 year.

[0082] In certain embodiments, the one or more first modules include a vagus nerve stimulation module, the vagus nerve stimulation module including one or more first tasks for reducing inflammation in the subject. In certain embodiments, the one or more first modules include a vagus nerve stimulation module, the vagus nerve stimulation module including at least one task selected from the group consisting of sensory stimulation tasks for vision, hearing, touch, taste, and smell. In certain embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for vision. In certain embodiments, the one or more sensory stimulation tasks for vision include one or more tasks for viewing one or more pictures or photographs to stimulate the autonomic nervous system. In certain embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for hearing. In certain embodiments, the one or more sensory stimulation tasks for hearing include one or more tasks for hearing one or more sounds to induce fear or relaxation. In certain embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch. In certain embodiments, the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing, breathing rate control, cooling massage, coughing, and skin massage. In some embodiments, the cooling massage includes decreasing a temperature of the subject's face. In certain embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch. In certain embodiments, the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing. In certain embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for taste. In certain embodiments, the one or more sensory stimulation tasks for taste include one or more tasks encouraging eating food to stimulate the subject's digestive glands. In certain embodiments, the vagus nerve stimulation module includes one or more sensory stimulation tasks for smell. In certain embodiments, the one or more sensory stimulation tasks for smell include one or more tasks to stimulate / stimulate or relax the digestive glands.

[0083] In certain embodiments, the one or more first modules include an aerobic exercise module, the aerobic exercise module including one or more first tasks for increasing adiponectin secretion in the subject, in certain embodiments, the one or more first tasks include one or more tasks for walking, cycling, aerobic dancing, and / or swimming.

[0084] In certain embodiments, the one or more first modules include a relaxation module, and the relaxation module includes one or more first tasks for increasing adiponectin secretion in the subject. In certain embodiments, the one or more first tasks for increasing adiponectin secretion in the subject include one or more meditation tasks. In certain embodiments, the one or more first tasks for increasing adiponectin secretion in the subject include one or more auditory tasks for listening to relaxing sounds. In some embodiments, the one or more auditory tasks include generating relaxing sounds, including, for example, white noise. In further embodiments, the device described herein includes a speaker configured to generate relaxing sounds. One mechanism by which adiponectin can be increased is vagus nerve stimulation, which produces anti-inflammatory effects and protein degradation blockade. In some embodiments, the relaxation module includes meditation. In some embodiments, the relaxation module includes deep breathing. In some embodiments, the relaxation module allows for abdominal nerve stimulation. In some embodiments, the relaxation module is performed in an atmosphere or environment in which the patient relaxes. In some embodiments, the relaxation module includes listening to music. Such modules can be repeated daily and the effects can be observed after 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months or 1 year.

[0085] A session can include any number of digital therapeutic modules. In some embodiments, a session can include two or more digital therapeutic modules. In some embodiments, a session can include three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, ten or more, eleven or more, twelve or more, thirteen or more, fourteen or more, fifteen or more, twenty or more, or twenty-five or more digital therapeutic modules. A session can include any number of digital therapeutic modules, where the digital therapeutic modules can be independently selected from a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module. In some embodiments, a session can consist of four digital therapeutic modules, where the digital therapeutic modules include a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module. Those of ordinary skill in the art will appreciate that there are a vast number of combinations for the number and type of digital therapeutic modules that can go into a particular session. A session can be repeated as frequently or infrequently as needed. In some embodiments, sessions may be repeated 5 times a day, 4 times a day, 3 times a day, twice a day, daily, every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 2 weeks, every 3 weeks, or every 4 weeks.

[0086] In the case of terminal cancer patients, it is believed that the voluntary skeletal muscle movement module may cause harm to the patient.Therefore, in certain embodiments of the present disclosure, if the subject has terminal cancer, the voluntary skeletal muscle movement module is excluded from the method or system for treating cancer cachexia.In certain embodiments of the present disclosure, if the subject has a cancer mass with a diameter of 0.1 centimeter (cm) or more, 0.5 cm or more, 1 cm or more, 2 cm or more, 3 cm or more, 4 cm or more, or 5 cm or more, the voluntary skeletal muscle movement module is excluded from the method or system for treating cancer cachexia.

[0087] In some embodiments, the subject has intermediate muscle atrophy and the one or more first modules comprise a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module. In some embodiments, the subject has intermediate muscle atrophy and the one or more first modules comprise a vagus nerve stimulation module, an aerobic movement module, and a relaxation module.

[0088] In some embodiments, the subject has severe muscular atrophy and the method excludes providing a voluntary skeletal muscle movement module and further excludes providing an aerobic movement module.

[0089] In some embodiments, the external reviewer includes a health professional (e.g., a health care provider or physician). In some embodiments, the external reviewer includes an artificial intelligence (AI). The term "artificial intelligence" may refer to the intelligence exhibited by a machine. In computer science, an ideal "intelligent" machine is a flexible and rational agent that perceives its environment and takes steps to maximize the likelihood of success in some goal (e.g., treating a patient's cancer cachexia). Colloquially, the term "artificial intelligence" is applied when a machine mimics the "cognitive" functions that humans associate with other human minds, such as "learning" and "problem solving." The term artificial intelligence may refer to algorithms that can apply learning techniques to various types of information (such as physiological information, additional information, and an individual's medical history).

[0090] In some embodiments, the digital device includes a sensor, the sensor including one or more of a camera, an accelerometer, a magnetometer, a light sensor, a microphone, a proximity sensor, a touch sensor, a gyroscope, a Global Positioning System (GPS) sensor, an ambient light sensor, a fingerprint sensor, a pedometer, a heart rate sensor, a thermometer, gesture recognition, and face recognition. In some embodiments, the sensor includes a touch sensor, and the subject uses the touch sensor to provide the adherence information to the electronic device.

[0091] FIG. 9 illustrates a flow chart illustrating a system for treating cancer cachexia, the system including an administration portal (e.g., administrator web), a healthcare provider portal (e.g., physician web) and a digital device configured to run a digital application (e.g., application or "app") for treating cancer cachexia from a subject. Among other things, the administrator portal allows an administrator to issue physician accounts, review physician information, and review de-identified patient information. Among other things, the healthcare provider portal allows a healthcare provider (e.g., physician) to issue patient accounts and review patient information (e.g., age, prescription information, and status of completing one or more digital therapeutic modules or sessions). Among other things, the digital application allows patient access to complete one or more digital therapeutic modules or sessions.

[0092] 10A and 10B are flow charts illustrating the flow of use of an exemplary digital application of the present disclosure.

[0093] 11 illustrates a flow chart illustrating the flow of execution for login verification during a splash process upon initiation of a digital application. The prescription verification process may also include, for example, determining if a treatment period has expired, determining if the subject has recently performed voluntary skeletal muscle exercise (e.g., within the last hour), and determining if the subject's sessions for that day based on the prescription have been completed (e.g., the subject is compliant with the prescription). In such cases, the digital device may inform the subject that no sessions are available for completion.

[0094] FIG. 12 is a flow chart illustrating an exemplary patient portal structure of the digital application of the present disclosure. FIG. 13 is a flow chart illustrating an exemplary patient portal use flow of the external activities of the digital application of the present disclosure. FIG. 14 is a flow chart illustrating an exemplary internal activities use flow of the digital application of the present disclosure. FIG. 15 is a flow chart illustrating an exemplary physician portal structure and an administrative portal structure of the digital application of the present disclosure. FIG. 16 is a flow chart illustrating an exemplary execution flow for the administrative portal in the system of the present disclosure.

[0095] In some embodiments, the healthcare provider portal provides one or more options to the healthcare provider, the one or more options provided to the healthcare provider selected from the group consisting of adding or removing a subject, viewing or editing personal information about the subject, viewing compliance information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic modules, prescribing one or more digital therapeutic modules to the subject, changing the prescription for one or more digital therapeutic modules, and communicating with the subject. In some embodiments, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, date, the subject's date of birth, the subject's email, the subject's guardian email, a contact phone number for the subject, a prescription for the subject, and one or more notes made by the healthcare provider for the subject. In some embodiments, the personal information includes a prescription for the subject, the prescription for the subject including one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, a number of digital therapeutic modules scheduled or prescribed by the subject, and a number of digital therapeutic modules scheduled or prescribed by the subject per day. In some embodiments, the one or more options include viewing compliance information, where the subject's compliance information includes one or more of: a number of scheduled or prescribed digital therapeutic modules completed by the subject, and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.In some embodiments, the one or more options include viewing subject outcomes, where the subject outcomes for one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of: a time when the subject started a scheduled or prescribed digital therapeutic module, a time when the subject finished a scheduled or prescribed digital therapeutic module, and an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed.

[0096] The healthcare provider portal dashboard will now be described in more detail. The healthcare provider portal dashboard may include a count of all patients currently associated with the physician's account. A graph may be used to show the number of patients who have started a digital application per day for the patient for the last 90 days. The number of ongoing patients may also be viewed. A graph may be used to show the number of patients who have completed a daily session per day for the last 90 days. The healthcare provider portal may include a Patients tab that displays a list of patients, for example, by displaying the patient ID (a unique identification number temporarily assigned to each patient when adding the patient to the list), the patient name, a search bar to search by ID, name, email, notes, etc., and an Add New Patient button to add a new patient. The Patients tab may further display detailed information about a given patient, for example, patient details, a button to edit the patient information, prescription information, a button to add a new prescription, progress status for each different prescription, and a button or link to send an email to the patient. The healthcare provider portal Patients tab may further have an option to add a new patient, for example, a button to add a new patient, and may display an error message if the required patient information is not provided. The healthcare provider portal patient tab may further include options to edit existing patient information, for example by providing buttons or links to reset passwords, buttons to delete the given patient, and buttons to save changes. Also, detailed prescription information for a given patient may be displayed. For example, the healthcare provider portal patient tab may include or display buttons to edit prescription information, duration of sessions attended by the patient or subject, and treatment progress summary. Seven days are represented by a line or row of seven squares. Twelve weeks may be presented, each six weeks separately. Different colors may be used to differentiate session status (e.g., grey for sessions not started, red for sessions not attended, yellow for sessions partially attended, green for sessions fully attended).In some embodiments, the administration portal provides one or more options to an administrator, the one or more options provided to an administrator of the system selected from the group consisting of adding or removing a healthcare provider, viewing or editing personal information about the healthcare provider, viewing or editing de-identified information about the subject, viewing adherence information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic modules, and communicating with a healthcare provider. In some embodiments, the one or more options include viewing or editing personal information, the healthcare provider's personal information including one or more selected from the group consisting of an identification number for the healthcare provider, the healthcare provider's name, the healthcare provider's email, and a contact phone number for the healthcare provider. In some embodiments, the one or more options include viewing or editing de-identified information about the subject, the subject's de-identified information including one or more selected from the group consisting of an identification number for the subject and a healthcare provider for the subject. In some embodiments, the one or more options include viewing adherence information about the subject, the subject's adherence information including one or more of a number of scheduled or prescribed digital therapeutic modules completed by the subject, and a calendar identifying one or more dates on which the subject has completed, partially completed, or not completed one or more scheduled or prescribed digital therapeutic modules. In some embodiments, the one or more options include viewing subject outcomes, where the subject outcomes for one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of: a time when the subject started a scheduled or prescribed digital therapeutic module, a time when the subject finished a scheduled or prescribed digital therapeutic module, and an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed.

[0097] The Administration Portal dashboard can show the number of doctors. A graph can be used to show the number of doctors who have visited the digital application in a day for the last 90 days. The number of all patients associated with any doctor account can be displayed on the Administration Portal. A graph can be used to show the number of patients who have started the digital application for a patient in a day for the last 90 days. The number of ongoing patients can also be seen. A graph can be used to show the number of patients who have completed a day session in a day for the last 90 days. The Administration Portal Doctors tab can display a list of doctors with a search bar to search various doctors e.g. by name, email etc., a button to add a new doctor, the doctor's ID, a button to view detailed doctor information and display deactivated doctor accounts. The Administration Portal Doctors tab further displays a list of patients being treated by a given doctor and the patient identifying information is removed (*). For example, the Doctor tab displays the doctor's account information, a button to edit the doctor's account information, a list of patients the doctor is treating, a list of patient ID numbers, a link or button to send a registration email to the doctor, a notification that the doctor's account has been deactivated that is only visible for deactivated accounts, and deleted or de-identified patient information. The Doctor tab of the Administration Portal may have options for editing existing doctor's information including adding a new doctor, activating or deactivating a doctor account, etc. The Patient tab of the Administration Portal also displays information about one or more patients, where sensitive information is removed. For example, the Patient tab of the Administration Portal may display detailed patient or prescription information for a given patient or detailed prescription information for a given patient.

[0098] Although the present disclosure has been illustrated and described with reference to specific exemplary embodiments thereof, it will be understood by those of ordinary skill in the art that various changes in form and details may be made therein without departing from the spirit and scope of the present disclosure as defined by the appended claims.

[0099] Specific Embodiments Embodiment 1. A method of treating cancer cachexia in a subject in need of such treatment, the method comprising the steps of: providing to the subject, by an electronic device, one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, each of the one or more first modules including one or more first tasks to be followed by the subject, the electronic device providing the one or more first modules, the one or more first modules including a sensor for sensing a degree of compliance by the subject with a first task of the one or more first modules, (ii) transmitting compliance information to a server based on the degree of compliance, and (iii) receiving one or more second tasks from the server based on the compliance information; and providing to the subject, by the electronic device, one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, the one or more second modules including one or more second tasks.

[0100] Embodiment 2. In the method according to embodiment 1, the one or more first modules include a voluntary skeletal muscle movement module, and the voluntary skeletal muscle movement module includes one or more first tasks for increasing MGF / IGF-1 secretion in the subject.

[0101] Embodiment 3. The method according to embodiment 2, wherein the one or more first tasks include tasks for aerobic exercise, resistance exercise and / or simultaneous exercise.

[0102] Embodiment 4. In a method according to any one of embodiments 1 to 3, the one or more first modules include a vagus nerve stimulation module, and the vagus nerve stimulation module includes one or more first tasks for reducing inflammation in a subject.

[0103] Embodiment 5. In a method according to any one of embodiments 1 to 4, the one or more first modules include a vagus nerve stimulation module, which includes at least one task selected from the group consisting of sensory stimulation tasks for vision, hearing, touch, taste, and smell.

[0104] Embodiment 6. In a method according to embodiment 5, the vagus nerve stimulation module includes one or more sensory stimulation tasks for vision, and the one or more sensory stimulation tasks for vision include one or more tasks for viewing one or more pictures to stimulate the autonomic nervous system.

[0105] Embodiment 7. In the method according to embodiment 6, the electronic device receives and displays the picture.

[0106] Embodiment 8. In a method according to any one of embodiments 5 to 7, the vagus nerve stimulation module includes one or more sensory stimulation tasks for hearing, and the one or more sensory stimulation tasks for hearing include one or more tasks for listening to one or more sounds to induce fear or relaxation.

[0107] Embodiment 9. In the method according to embodiment 8, the electronic device receives and plays the sound.

[0108] Embodiment 10. In a method according to any one of embodiments 5 to 9, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, and the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing, breathing rate control, cooling massage, coughing, and skin massage.

[0109] Embodiment 11. In a method according to any one of embodiments 5 to 10, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, and the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing.

[0110] Embodiment 12. In a method according to any one of embodiments 5 to 11, the vagus nerve stimulation module includes one or more sensory stimulation tasks for taste, and the one or more sensory stimulation tasks for taste include one or more tasks encouraging the subject to eat food to stimulate the subject's digestive glands.

[0111]

[0046] Embodiment 13. The method of embodiment 12, wherein the electronic device receives and displays food-related information.

[0112] Embodiment 14. In a method according to any one of embodiments 5 to 13, the vagus nerve stimulation module includes one or more sensory stimulation tasks for the sense of smell, and the one or more sensory stimulation tasks for the sense of smell include one or more tasks for stimulating / stimulating or relaxing the digestive gland.

[0113] Embodiment 15. In the method according to embodiment 14, the electronic device is configured to emit a scent for aromatherapy.

[0114] Embodiment 16. In a method according to any one of embodiments 1 to 15, the one or more first modules include an aerobic exercise module, and the aerobic exercise module includes one or more first tasks for increasing adiponectin secretion in a subject.

[0115] Embodiment 17. In the method according to embodiment 16, the one or more first tasks include one or more tasks for walking, cycling, aerobic dancing and / or swimming.

[0116] Embodiment 18. In a method according to any one of embodiments 1 to 17, the one or more first modules include a relaxation module, and the relaxation module includes one or more first tasks for increasing adiponectin secretion in a subject.

[0117] Embodiment 19. In the method according to embodiment 18, the one or more first tasks include one or more meditation tasks.

[0118] Embodiment 20. In a method according to embodiment 18 or embodiment 19, the one or more first tasks include one or more auditory tasks for listening to relaxing sounds.

[0119] Embodiment 21. In the method according to embodiment 20, the device receives and plays relaxing sounds.

[0120] Embodiment 22 In the method according to any one of embodiments 1 to 21, the subject is an early stage cancer patient.

[0121] Embodiment 23 In the method according to any one of embodiments 1 to 21, the subject has a cancer mass having a diameter of 3 cm or less.

[0122] Embodiment 24. In the method according to any one of embodiment 1 and embodiment 4 to embodiment 21, the subject is a terminal cancer patient, and the method excludes the step of providing a voluntary skeletal muscle motor module.

[0123] Embodiment 25. In a method according to any one of embodiment 1 and embodiments 4 to 21, the subject has a cancer mass having a diameter of more than 3 cm, and the method excludes providing a voluntary skeletal muscle motor module.

[0124] Embodiment 26 In the method according to embodiment 22 or embodiment 23, the subject has intermediate muscle atrophy, and the one or more first modules consist of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module.

[0125] Embodiment 27. In the method according to embodiment 25 or embodiment 26, the subject has intermediate muscle atrophy, and the one or more first modules consist of a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module.

[0126] Embodiment 28. In the method according to any one of embodiments 1 to 27, the subject has intermediate muscle atrophy (defined in the specification as still being able to walk).

[0127] Embodiment 29. In a method according to any one of embodiments 1, 4 to 15, and 18 to 25, the subject has severe muscular atrophy, and the method excludes the step of providing a voluntary skeletal muscle movement module and further excludes the step of providing an aerobic movement module.

[0128] Embodiment 30. In the method according to embodiment 29, the one or more first modules comprise a vagus nerve stimulation module and a relaxation module.

[0129] Embodiment 31 In the method according to any one of embodiments 1 to 30, the server receives one or more second challenges from an external reviewer.

[0130] Embodiment 32. In the method according to any one of embodiments 1 to 31, the external reviewer comprises a health professional.

[0131] Embodiment 33. In the method according to any one of embodiments 1 to 32, the external reviewer includes an artificial intelligence (AI).

[0132] Embodiment 34. In a method according to any one of embodiments 1 to 33, the sensor includes one or more of a camera, an accelerometer, a magnetometer, a light sensor, a microphone, a proximity sensor, a touch sensor, a gyroscope, a global positioning system (GPS) sensor, an ambient light sensor, a fingerprint sensor, a pedometer, a heart rate sensor, and a thermometer.

[0133] Embodiment 35. In the method according to any one of embodiments 1 to 34, the sensor includes a touch sensor, and the subject uses the touch sensor to provide the compliance information to the electronic device.

[0134] Embodiment 36. A system for treating cancer cachexia in a subject, comprising: a digital device configured to execute a digital application including one or more first modules for treating cancer cachexia in a subject, the digital device including a sensor for sensing the subject's compliance with a first set of tasks of the one or more first modules; a healthcare provider portal configured to provide one or more options to a healthcare provider to perform one or more actions for prescribing treatment for the subject's cancer cachexia based on information received from the digital application; and an administration portal configured to provide one or more options to an administrator of the system to perform one or more actions for managing access to the system by the healthcare provider.

[0135] Embodiment 37 In the system of embodiment 36, the digital application for treating cancer cachexia comprises a processor of the digital device that: The method instructs the user to perform operations including generating a digital therapeutic agent module for treating cancer cachexia based on a mechanism of action and a treatment hypothesis for cancer cachexia.

[0136] Embodiment 38 In the system of embodiment 37, generating the digital therapeutic module includes generating the digital therapeutic module based on biochemical factors associated with cancer cachexia.

[0137] Embodiment 39. In a system according to embodiment 36, the one or more first modules include a voluntary skeletal muscle movement module, and the voluntary skeletal muscle movement module includes one or more first tasks for increasing MGF / IGF-1 secretion in a subject.

[0138] Embodiment 40. In the system according to embodiment 39, the one or more first tasks include tasks for aerobic exercise, resistance exercise and / or simultaneous exercise.

[0139] Embodiment 41. In a system according to any one of embodiments 36 to 40, the one or more first modules include a vagus nerve stimulation module, and the vagus nerve stimulation module includes one or more first tasks for reducing inflammation in a subject.

[0140] Embodiment 42. In a system according to any one of embodiments 36 to 41, the one or more first modules include a vagus nerve stimulation module, which includes at least one task selected from the group consisting of sensory stimulation tasks for vision, hearing, touch, taste, and smell.

[0141] Embodiment 43. In a system according to embodiment 42, the vagus nerve stimulation module includes one or more sensory stimulation tasks for vision, and the one or more sensory stimulation tasks for vision include one or more tasks for viewing one or more pictures (defined in the specification to include specific photographs) to stimulate the autonomic nervous system.

[0142] Embodiment 44 In the system according to embodiment 43, the electronic device receives and displays a picture.

[0143] Embodiment 45. In a system according to any one of embodiments 42 to 44, the vagus nerve stimulation module includes one or more sensory stimulation tasks for hearing, and the one or more sensory stimulation tasks for hearing include one or more tasks for listening to one or more sounds to induce fear or relaxation.

[0144] Embodiment 46 In the system according to embodiment 45, the electronic device receives and plays sound.

[0145] Embodiment 47. In a system according to any one of embodiments 42 to 46, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, and the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing, breathing rate control, cooling massage, coughing, and skin massage.

[0146] Embodiment 48. In a system according to any one of embodiments 42 to 47, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, and the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing.

[0147] Embodiment 49. In a system according to any one of embodiments 42 to 48, the vagus nerve stimulation module includes one or more sensory stimulation tasks for taste, and the one or more sensory stimulation tasks for taste include one or more tasks encouraging the subject to eat food to stimulate the subject's digestive glands.

[0148] Embodiment 50 In the system according to embodiment 49, the electronic device receives and displays information related to food.

[0149] Embodiment 51. In a system according to any one of embodiments 42 to 50, the vagus nerve stimulation module includes one or more sensory stimulation tasks for the sense of smell, and the one or more sensory stimulation tasks for the sense of smell include one or more tasks for stimulating / stimulating or relaxing the digestive gland.

[0150] Embodiment 52. In the system according to embodiment 51, the electronic device is configured to emit a scent for aromatherapy.

[0151] Embodiment 53. In a system according to any one of embodiments 36 to 52, the one or more first modules include an aerobic exercise module, and the aerobic exercise module includes one or more first tasks for increasing adiponectin secretion in a subject.

[0152] Embodiment 54. In the system according to embodiment 53, the one or more first tasks include one or more tasks for walking, cycling, aerobic dancing and / or swimming.

[0153] Embodiment 55. In a system according to any one of embodiments 36 to 54, the one or more first modules include a relaxation module, and the relaxation module includes one or more first tasks for increasing adiponectin secretion in a subject.

[0154] Embodiment 56. In the system according to embodiment 55, the one or more first tasks include one or more meditation tasks.

[0155] Embodiment 57. In a system according to embodiment 55 or embodiment 56, the one or more first tasks include one or more auditory tasks for listening to relaxing sounds.

[0156] Embodiment 58. In the system according to embodiment 57, the device receives and plays relaxing sounds.

[0157] Embodiment 59 In the system according to any one of embodiments 36 to 58, the subject is an early stage cancer patient.

[0158] Embodiment 60 In a system according to any one of embodiments 36 to 58, the subject has a cancer mass having a diameter of 3 cm or less.

[0159] Embodiment 61. In the system according to any one of embodiment 36 and embodiment 41 to embodiment 58, the subject is a terminal cancer patient, and the system excludes providing a voluntary skeletal muscle movement module.

[0160] Embodiment 62. In a system according to any one of embodiment 36 and embodiments 41 to 58, the subject has a cancer mass having a diameter of more than 3 cm, and the system excludes providing a voluntary skeletal muscle movement module.

[0161] Embodiment 63 In a system according to embodiment 59 or embodiment 60, the subject has intermediate muscle atrophy, and the one or more first modules consist of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module.

[0162] Embodiment 64 In the system according to embodiment 62 or embodiment 63, the subject has intermediate muscle atrophy, and the one or more first modules consist of a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module.

[0163] Embodiment 65 In a system according to any one of embodiments 36 to 64, the subject has intermediate muscle atrophy (in the specification, intermediate muscle atrophy is defined as still being able to walk).

[0164] Embodiment 66. In a system according to any one of embodiment 36, embodiments 41 to 52, and embodiments 55 to 62, the subject has severe muscular atrophy (in the specification, severe muscular atrophy is defined as the inability to walk), and the system excludes providing a voluntary skeletal muscle movement module and further excludes providing an aerobic movement module.

[0165] Embodiment 67 In the system according to embodiment 66, the one or more first modules comprise a vagus nerve stimulation module and a relaxation module.

[0166] Embodiment 68. In a system according to any one of embodiments 36 to 67, the digital application transmits data to a server, and the server receives one or more second tasks from an external reviewer.

[0167] Embodiment 69. In a system according to any one of embodiments 36 to 68, the external reviewer includes a health professional.

[0168] Embodiment 70: In the system according to any one of embodiments 36 to 69, the external reviewer includes an artificial intelligence (AI).

[0169] Embodiment 71. In a system according to any one of embodiments 36 to 70, the sensor includes one or more of a camera, an accelerometer, a magnetometer, a light sensor, a microphone, a proximity sensor, a touch sensor, a gyroscope, a global positioning system (GPS) sensor, an ambient light sensor, a fingerprint sensor, a pedometer, a heart rate sensor, and a thermometer.

[0170] Embodiment 72. In a system according to any one of embodiments 36 to 65, the sensor includes a touch sensor, and the subject uses the touch sensor to provide compliance information to the electronic device.

[0171] Embodiment 73. In a system according to any one of embodiments 36 to embodiment 72, the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing a subject, viewing or editing personal information about the subject, viewing compliance information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic agent modules, prescribing one or more digital therapeutic agent modules to the subject, changing the prescription for one or more digital therapeutic agent modules, and communicating with the subject.

[0172] Embodiment 74. In the system of embodiment 73, one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's guardian's email, a contact phone number for the subject, prescriptions for the subject, and one or more notes made by a healthcare provider for the subject.

[0173] Embodiment 75. In the system of embodiment 74, the personal information includes a prescription for the subject, and the prescription for the subject includes one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, a number of digital therapeutic modules scheduled or prescribed by the subject, and a number of digital therapeutic modules scheduled or prescribed by the subject per day.

[0174] Embodiment 76. In any one of the systems of embodiments 73 to 75, one or more options include viewing adherence information, and the subject's adherence information includes one or more of the number of scheduled or prescribed digital therapeutic modules completed by the subject, and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0175] Embodiment 77. In any one of the systems of embodiments 73 to 76, one or more options include viewing the subject's results, and the subject's results for one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapeutic module, the time the subject finished the scheduled or prescribed digital therapeutic module, an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI).

[0176] Embodiment 78. In the systems of embodiments 36 to 77, one or more options provided to a system administrator are selected from the group consisting of adding or removing a healthcare provider, viewing or editing personal information about a healthcare provider, viewing or editing de-identified information about a subject, viewing compliance information about a subject, viewing a subject's results for one or more at least partially completed digital therapeutic agent modules, and communicating with a healthcare provider.

[0177] Embodiment 79. In the system of embodiment 78, the one or more options include viewing or editing personal information, and the personal information of the healthcare provider includes one or more selected from the group consisting of an identification number for the healthcare provider, the name of the healthcare provider, the email of the healthcare provider, and a contact phone number for the healthcare provider.

[0178] Embodiment 80. In the system of embodiment 78 or embodiment 79, one or more options include viewing or editing the subject's de-identified information, wherein the subject's de-identified information includes one or more selected from the group consisting of an identification number for the subject and a health care provider for the subject.

[0179] Embodiment 81. In any one of the systems of embodiments 78 to 80, one or more options include viewing compliance information regarding the subject, the subject's compliance information including one or more of the number of scheduled or prescribed digital therapeutic modules completed by the subject, and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0180] Embodiment 82. In any one of the systems of embodiments 73 to 81, one or more options include viewing the subject's results, and the subject's results for one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapeutic module, the time the subject finished the scheduled or prescribed digital therapeutic module, an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI).

[0181] Embodiment 83. In the systems of embodiments 36 to 82, the digital application further includes a push alarm for one or more of reminding the subject to complete the digital therapeutic module.

[0182] Embodiment 84. In the systems of embodiments 36 to 83, the digital device includes a digital task generation unit configured to generate a digital therapeutic agent module for treating cancer cachexia, generate a digital task based on the digital therapeutic agent module, and provide the digital task to the subject, and a result collection unit configured to collect results of the subject's execution of the digital task.

[0183] Embodiment 85 In the systems of embodiments 36 to 84, the digital problem generator generates a digital therapeutic agent module based on biochemical factors associated with the onset of cancer cachexia.

[0184] Embodiment 86 In the system of embodiment 85, the biochemical factors include insulin-like growth factor 1 (IGF1) and hypoxia-inducible factor 1 (HIF1).

[0185] Embodiment 87 In the systems of embodiments 36 to 86, the digital task generator generates a digital therapeutic agent module based on input from a healthcare provider.

[0186] Embodiment 88 In the systems of embodiments 36 to 87, the digital task generator generates a digital therapeutic module based on information received from the subject.

[0187] Embodiment 89. In the system of embodiment 88, the information received from the subject includes at least one of the subject's baseline factors, medical information, and digital therapeutic literacy, where the baseline factors include the subject's activity, heart rate, sleep, and diet (including nutrients and calories), the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerabilities, and genetic susceptibility, and the digital therapeutic literacy includes the subject's accessibility and technology adoption to digital therapeutics and devices.

[0188] Embodiment 90. In the systems of embodiments 36 to 89, the digital problem generator generates a digital therapeutic agent module that matches virtual parameters corresponding to a treatment hypothesis and mechanism of action for cancer cachexia.

[0189] Embodiment 91. In the system of embodiment 90, virtual parameters are inferred in relation to the subject's environment, behavior, emotions and cognition.

[0190] Embodiment 92. In the systems of embodiments 36 to 91, the result collection unit collects the results of the execution of the digital tasks by monitoring the subject's compliance with the digital tasks or by allowing the subject to directly input the subject's compliance with the digital tasks.

[0191] Embodiment 93. In the systems of embodiments 36 to 92, the generation of digital tasks in the digital task generation unit and the collection of the results of the subjects' execution of the digital tasks in the result collection unit are repeated multiple times in multiple feedback loops, and the digital task generation unit generates the subject's digital tasks for such cycles based on the subject's digital tasks in the previous cycle and the execution result data for the subject's digital tasks in the previous cycle collected by the result collection unit.

[0192] Embodiment 94. A computing system for treating cancer cachexia from a subject in need of such treatment, comprising: a display configured to provide to the subject one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, each of the one or more first modules including one or more first tasks to be followed by the subject; a sensor configured to sense compliance by the subject with the tasks of the one or more first modules; a transmitter configured to transmit compliance information to a server based on the compliance; and a receiver configured to receive one or more second tasks from the server based on the compliance information, wherein the display is further configured to provide to the subject one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, each of the one or more second modules including one or more second tasks.

[0193] Embodiment 95. In the computing system of embodiment 94, the digital application for treating cancer cachexia instructs a processor of the digital device to perform operations including generating a digital therapeutic agent module for treating cancer cachexia based on a treatment hypothesis and mechanism of action for cancer cachexia.

[0194] Embodiment 96. In the computing system of embodiment 95, generating the digital therapeutic module includes generating the digital therapeutic module based on biochemical factors associated with cancer cachexia.

[0195] Embodiment 97. In the computing system of embodiment 94, the one or more first modules include a voluntary skeletal muscle movement module, and the voluntary skeletal muscle movement module includes one or more first tasks for increasing MGF / IGF-1 secretion in a subject.

[0196] Embodiment 98. In the computing system of embodiment 97, the one or more first tasks include tasks for aerobic exercise, resistance exercise and / or simultaneous exercise.

[0197] Embodiment 99. In any one of the computing systems of embodiments 94 to 98, the one or more first modules include a vagus nerve stimulation module, and the vagus nerve stimulation module includes one or more first tasks for reducing inflammation in a subject.

[0198] Embodiment 100. In any one of the computing systems of embodiments 94 to 99, the one or more first modules include a vagus nerve stimulation module, which includes at least one task selected from the group consisting of sensory stimulation tasks for vision, hearing, touch, taste, and smell.

[0199] Embodiment 101. In the computing system of embodiment 100, the vagus nerve stimulation module includes one or more sensory stimulation tasks for vision, which include one or more tasks for viewing one or more pictures (defined in the specification to include specific photographs) to stimulate the autonomic nervous system.

[0200] Embodiment 102. In the computing system of embodiment 101, the electronic device receives and displays a picture.

[0201] Embodiment 103. In any one of the computing systems of embodiments 100 to 102, the vagus nerve stimulation module includes one or more sensory stimulation tasks for hearing, and the one or more sensory stimulation tasks for hearing include one or more tasks for listening to one or more sounds to induce fear or relaxation.

[0202] Embodiment 104. In the computing system of embodiment 103, the electronic device receives and plays sound.

[0203] Embodiment 105. In any one of the computing systems of embodiments 100 to 104, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, and the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing, breathing rate control, cooling massage, coughing, and skin massage.

[0204] Embodiment 106. In any one of the computing systems of embodiments 100 to 105, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, and the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing.

[0205] Embodiment 107. In any one of the computing systems of embodiments 100 to 106, the vagus nerve stimulation module includes one or more sensory stimulation tasks for taste, and the one or more sensory stimulation tasks for taste include one or more tasks that recommend eating food to stimulate the subject's digestive glands.

[0206] Embodiment 108 In the computing system of embodiment 107, the electronic device receives and displays information related to food.

[0207] Embodiment 109. In any one of the computing systems of embodiments 100 to 108, the vagus nerve stimulation module includes one or more sensory stimulation tasks for the sense of smell, and the one or more sensory stimulation tasks for the sense of smell include one or more tasks for stimulating / stimulating or relaxing the digestive gland.

[0208] Embodiment 110. In the computing system of embodiment 109, the electronic device is configured to emit a scent for aromatherapy.

[0209] Embodiment 111. In any one of the computing systems of embodiments 94 to 110, the one or more first modules include an aerobic exercise module, and the aerobic exercise module includes one or more first tasks for increasing adiponectin secretion in a subject.

[0210] Embodiment 112. In the computing system of embodiment 111, the one or more first tasks include one or more tasks for walking, cycling, aerobic dancing, and / or swimming.

[0211] Embodiment 113. In any one of the computing systems of embodiments 94 to 112, the one or more first modules include a relaxation module, and the relaxation module includes one or more first tasks for increasing adiponectin secretion in a subject.

[0212] Embodiment 114. In the computing system of embodiment 113, the one or more first tasks include one or more meditation tasks.

[0213] Embodiment 115. In the computing system of embodiment 113 or embodiment 114, the one or more first tasks include one or more auditory tasks for listening to relaxing sounds.

[0214] Embodiment 116 In the computing system of embodiment 115, the device receives and plays back relaxing auditory sensations.

[0215] Embodiment 117: In the computing system of any one of embodiments 94 to 116, the subject is an early stage cancer patient.

[0216] Embodiment 118 In the computing system of any one of embodiments 94 to 116, the subject has a cancer mass having a diameter of 3 cm or less.

[0217] Embodiment 119. In the computing system of any one of embodiment 94 and embodiment 99 to embodiment 116, the subject is a terminal cancer patient, and the system excludes providing a voluntary skeletal muscle movement module.

[0218] Embodiment 120. In any one of the computing systems of embodiments 94 and embodiments 99 to 116, the subject has a cancer mass having a diameter of greater than 3 cm, and the system excludes providing a voluntary skeletal muscle movement module.

[0219] Embodiment 121. In the computing system of embodiment 117 or embodiment 118, the subject has intermediate muscle atrophy, and the one or more first modules consist of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module.

[0220] Embodiment 122. In the computing system of embodiment 120 or embodiment 121, the subject has intermediate muscle atrophy, and the one or more first modules consist of a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module.

[0221] Embodiment 123. In the computing system of any one of embodiments 94 to 122, the subject has intermediate muscle atrophy (defined in the specification as still being able to walk).

[0222] Embodiment 124. In any one of the computing systems of embodiment 94, embodiment 99 to embodiment 110, and embodiment 113 to embodiment 120, the subject has severe muscular atrophy (as defined in the specification, severe muscular atrophy is the inability to walk), and the system excludes providing a voluntary skeletal muscle movement module and further excludes providing an aerobic movement module.

[0223] Embodiment 125. In the computing system of embodiment 125, the one or more first modules comprise a vagus nerve stimulation module and a relaxation module.

[0224] Embodiment 126. In a computing system according to any one of embodiments 94 to 125, the digital application transmits data to a server, and the server receives one or more second tasks from an external reviewer.

[0225] Embodiment 127. In the computing system of any one of embodiments 94 to 126, the external reviewer includes a health professional.

[0226] Embodiment 128. In the computing system of any one of embodiments 94 to 127, the external reviewer includes an artificial intelligence (AI).

[0227] Embodiment 129. In any one of the computing systems of embodiments 94 to 128, the sensor includes one or more of a camera, an accelerometer, a magnetometer, a light sensor, a microphone, a proximity sensor, a touch sensor, a gyroscope, a global positioning system (GPS) sensor, an ambient light sensor, a fingerprint sensor, a pedometer, a heart rate sensor, and a thermometer.

[0228] Embodiment 130. In the computing system of any one of embodiments 94 to 123, the sensor includes a touch sensor, and the subject uses the touch sensor to provide compliance information to the electronic device.

[0229] Embodiment 131. In the computing systems of embodiments 94 to 130, the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing a subject, viewing or editing personal information about the subject, viewing compliance information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic agent modules, prescribing one or more digital therapeutic agent modules to the subject, changing the prescription for one or more digital therapeutic agent modules, and communicating with the subject.

[0230] Embodiment 132. In the computing system of embodiment 131, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's guardian's email, a contact phone number for the subject, prescriptions for the subject, and one or more notes made by a healthcare provider for the subject.

[0231] Embodiment 133. In the computing system of embodiment 132, the personal information includes a prescription for the subject, the prescription for the subject including one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, a number of digital therapeutic modules scheduled or prescribed by the subject, and a number of digital therapeutic modules scheduled or prescribed by the subject per day.

[0232] Embodiment 134. In the computing system of embodiment 131, one or more options include viewing adherence information, where the subject's adherence information includes one or more of the number of scheduled or prescribed digital therapeutic modules completed by the subject, and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0233] Embodiment 135. In the computing system of embodiment 131, one or more options include viewing the subject's results, where the subject's results for one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapeutic module, the time the subject finished the scheduled or prescribed digital therapeutic module, an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI).

[0234] Embodiment 136. In the computing systems of embodiments 94 to 135, one or more options provided to an administrator of the system are selected from the group consisting of adding or removing a healthcare provider, viewing or editing personal information about a healthcare provider, viewing or editing de-identified information about a subject, viewing compliance information about a subject, viewing a subject's results for one or more at least partially completed digital therapeutic agent modules, and communicating with a healthcare provider.

[0235] Embodiment 137. In the computing system of embodiment 136, the one or more options include viewing or editing personal information, and the personal information of the healthcare provider includes one or more selected from the group consisting of an identification number for the healthcare provider, the name of the healthcare provider, an email of the healthcare provider, and a contact phone number for the healthcare provider.

[0236] Embodiment 138. In the computing system of embodiment 136, one or more options include viewing or editing the subject's de-identified information, the subject's de-identified information including one or more selected from the group consisting of an identification number for the subject and a health care provider for the subject.

[0237] Embodiment 139. In the computing system of embodiment 136, one or more options include viewing adherence information for the subject, the subject's adherence information including one or more of the number of scheduled or prescribed digital therapeutic modules completed by the subject, and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0238] Embodiment 140. In the computing system of embodiment 136, one or more options include viewing the subject's results, where the subject's results for one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapeutic module, the time the subject finished the scheduled or prescribed digital therapeutic module, an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI).

[0239] Embodiment 141. In the computing systems of embodiments 94 to 140, the digital application further includes a push alarm for one or more of reminding the subject to complete the digital therapeutic agent module.

[0240] Embodiment 142. In the computing systems of embodiments 94 to 141, the digital device includes a digital task generation unit configured to generate a digital therapeutic agent module for treating cancer cachexia, generate a digital task based on the digital therapeutic agent module, and provide the digital task to a subject, and a result collection unit configured to collect results of the subject's execution of the digital task.

[0241] Embodiment 143 In the computing system of any of embodiments 94 to 142, the digital problem generator generates a digital therapeutic agent module based on biochemical factors associated with the onset of cancer cachexia.

[0242] Embodiment 144. In the computing system of embodiment 143, the biochemical factors include insulin-like growth factor 1 (IGF1) and hypoxia-inducible factor 1 (HIF1).

[0243] Embodiment 145. In the computing system of any of embodiments 94 to 144, the digital problem generator generates a digital therapeutic agent module based on input from a healthcare provider.

[0244] Embodiment 146 In the computing system of any of embodiments 94 to 145, the digital task generator generates a digital therapeutic module based on information received from the subject.

[0245] Embodiment 147. In the computing system of embodiment 146, the information received from the subject includes at least one of the subject's baseline factors, medical information, and digital therapeutic agent comprehension capabilities, where the baseline factors include the subject's activity, heart rate, sleep, and diet (including nutrients and calories), the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerabilities and genetic susceptibilities, and the digital therapeutic agent comprehension capabilities include the subject's accessibility and technology adoption to digital therapeutics and devices.

[0246] Embodiment 148 In the computing system of embodiments 94 to 147, the digital problem generator generates a digital therapeutic agent module that matches virtual parameters corresponding to a treatment hypothesis and mechanism of action for cancer cachexia.

[0247] Embodiment 149. In the computing system of embodiment 90, virtual parameters are inferred in relation to the subject's environment, behavior, emotions and cognition.

[0248] Embodiment 150. In the computing systems of embodiments 94 to 149, the result collection unit collects the results of the execution of the digital tasks by monitoring the subject's compliance with the digital tasks or by allowing the subject to directly input the subject's compliance with the digital tasks.

[0249] Embodiment 151. In the computing systems of embodiments 94 to 150, the generation of digital tasks in the digital task generation unit and the collection of subject execution results of the digital tasks in the result collection unit are performed multiple times in multiple feedback loops, and the digital task generation unit generates the subject's digital tasks for such cycles based on the subject's digital tasks in the previous cycle and the execution result data for the subject's digital tasks in the previous cycle collected by the result collection unit.

[0250] Embodiment 152. A non-transitory computer-readable medium storing software instructions for treating cancer cachexia from a subject in need of such treatment, the software instructions, when executed by a processor, to the processor: cause an electronic device to display to the subject one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, each of the one or more first modules including a task to be followed by the subject; cause a sensor of the electronic device to sense compliance by the subject with the tasks of the one or more first modules; cause the electronic device to transmit compliance information to a server based on the compliance; cause the electronic device to receive one or more second tasks from the server based on the compliance information; cause an electronic device to display to the subject one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module, each of the one or more first modules including one or more second tasks.

[0251] Embodiment 153. In the non-transitory computer-readable medium of embodiment 152, the digital application for treating cancer cachexia instructs a processor of the digital device to perform operations including generating a digital therapeutic agent module for treating cancer cachexia based on a treatment hypothesis and mechanism of action for cancer cachexia.

[0252] Embodiment 154. In the non-transitory computer-readable medium of embodiment 153, generating the digital therapeutic module includes generating the digital therapeutic module based on biochemical factors associated with cancer cachexia.

[0253] Embodiment 155. In the non-transitory computer-readable medium of embodiment 152, the one or more first modules include a voluntary skeletal muscle movement module, and the voluntary skeletal muscle movement module includes one or more first tasks for increasing MGF / IGF-1 secretion in a subject.

[0254] Embodiment 156. In the non-transitory computer-readable medium of embodiment 155, the one or more first tasks include tasks for aerobic exercise, resistance exercise and / or simultaneous exercise.

[0255] Embodiment 157. In any one of the non-transitory computer-readable media of embodiments 152 to 156, the one or more first modules include a vagus nerve stimulation module, and the vagus nerve stimulation module includes one or more first tasks for reducing inflammation in a subject.

[0256] Embodiment 158. In any one of the non-transitory computer-readable media of embodiments 152 to 157, the one or more first modules include a vagus nerve stimulation module, which includes at least one task selected from the group consisting of sensory stimulation tasks for vision, hearing, touch, taste, and smell.

[0257] Embodiment 159. In the non-transitory computer-readable medium of embodiment 158, the vagus nerve stimulation module includes one or more sensory stimulation tasks for vision, and the one or more sensory stimulation tasks for vision include one or more tasks for viewing one or more pictures (defined in the specification to include specific photographs) to stimulate the autonomic nervous system.

[0258] Embodiment 160. In the non-transitory computer-readable medium of embodiment 159, an electronic device receives and displays a picture.

[0259] Embodiment 161. In any one of the non-transitory computer-readable media of embodiments 158 to 160, the vagus nerve stimulation module includes one or more sensory stimulation tasks for hearing, and the one or more sensory stimulation tasks for hearing include one or more tasks for listening to one or more sounds to induce fear or relaxation.

[0260] Embodiment 162. In the non-transitory computer-readable medium of embodiment 161, the electronic device receives and plays sound.

[0261] Embodiment 163. In any one of the non-transitory computer-readable media of embodiments 158 to 162, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, and the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing, breathing rate control, cooling massage, coughing, and skin massage.

[0262] Embodiment 164. In any one of the non-transitory computer-readable media of embodiments 158 to 163, the vagus nerve stimulation module includes one or more sensory stimulation tasks for touch, and the one or more sensory stimulation tasks for touch include one or more tasks for abdominal breathing.

[0263] Embodiment 165. In any one of the non-transitory computer-readable media of embodiments 158 to 164, the vagus nerve stimulation module includes one or more sensory stimulation tasks for taste, and the one or more sensory stimulation tasks for taste include one or more tasks that recommend eating food to stimulate the subject's digestive glands.

[0264] Embodiment 166 In the non-transitory computer-readable medium of embodiment 165, the electronic device receives and displays information related to food.

[0265] Embodiment 167. In any one of the non-transitory computer-readable media of embodiments 158 to 166, the vagus nerve stimulation module includes one or more sensory stimulation tasks for the sense of smell, and the one or more sensory stimulation tasks for the sense of smell include one or more tasks for stimulating / stimulating or relaxing the digestive gland.

[0266] Embodiment 168. In the non-transitory computer-readable medium of embodiment 167, the electronic device is configured to emit a scent for aromatherapy.

[0267] Embodiment 169. In any one of the non-transitory computer-readable media of embodiments 152 to 168, the one or more first modules include an aerobic exercise module, and the aerobic exercise module includes one or more first tasks for increasing adiponectin secretion in a subject.

[0268] Embodiment 170. In the non-transitory computer-readable medium of embodiment 169, the one or more first tasks include one or more tasks for walking, cycling, aerobic dancing, and / or swimming.

[0269] Embodiment 171. In any one of the non-transitory computer-readable media of embodiments 152 to 170, the one or more first modules include a relaxation module, and the relaxation module includes one or more first tasks for increasing adiponectin secretion in a subject.

[0270] Embodiment 172. In the non-transitory computer-readable medium of embodiment 171, the one or more first tasks include one or more meditation tasks.

[0271] Embodiment 173. In the non-transitory computer-readable medium of embodiment 171 or embodiment 172, the one or more first tasks include one or more auditory tasks for listening to relaxing sounds.

[0272] Embodiment 174. In the non-transitory computer-readable medium of embodiment 173, the device receives and plays relaxing sounds.

[0273] Embodiment 175. In the non-transitory computer-readable medium of any one of embodiments 152 to 174, the subject is an early stage cancer patient.

[0274] Embodiment 176. In the non-transitory computer-readable medium of any one of embodiments 152 to 174, the subject has a cancer mass having a diameter of 3 cm or less.

[0275] Embodiment 177. In the non-transitory computer-readable medium of any one of embodiments 152 and embodiments 157 to 158, the subject is a terminal cancer patient, and the system excludes providing a voluntary skeletal muscle movement module.

[0276] Embodiment 178. In any one of the non-transitory computer-readable media of embodiment 152 and embodiments 157 to 158, the subject has a cancer mass having a diameter of greater than 3 cm, and the system excludes providing a voluntary skeletal muscle movement module.

[0277] Embodiment 179. In the non-transitory computer-readable medium of embodiment 175 or embodiment 176, the subject has intermediate muscle atrophy, and the one or more first modules consist of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module.

[0278] Embodiment 180. In the non-transitory computer-readable medium of embodiment 178 or embodiment 179, the subject has intermediate muscle atrophy, and the one or more first modules consist of a vagus nerve stimulation module, an aerobic exercise module, and a relaxation module.

[0279] Embodiment 181. In any one of the non-transitory computer-readable media of embodiments 152 to 180, the subject has intermediate muscle atrophy (defined in the specification as being still able to walk).

[0280] Embodiment 182. In any one of the non-transitory computer-readable media of embodiment 152, embodiments 157 to 168, and embodiments 171 to 178, the subject has severe muscular atrophy (as defined in the specification, severe muscular atrophy is the inability to walk), and the system excludes providing a voluntary skeletal muscle movement module and further excludes providing an aerobic movement module.

[0281] Embodiment 183. In the non-transitory computer-readable medium of embodiment 182, the one or more first modules comprise a vagus nerve stimulation module and a relaxation module.

[0282] Embodiment 184. In the non-transitory computer-readable medium of any one of embodiments 152 to 183, the digital application transfers data to a server, and the server receives one or more second tasks from an external reviewer.

[0283] Embodiment 185. In the non-transitory computer-readable medium of any one of embodiments 152 to 184, the external reviewer includes a health professional.

[0284] Embodiment 186. In the non-transitory computer-readable medium of any one of embodiments 152 to 185, the external reviewer includes artificial intelligence (AI).

[0285] Embodiment 187. In any one of the non-transitory computer-readable media of embodiments 152 to 186, the sensor includes one or more of a camera, an accelerometer, a magnetometer, a light sensor, a microphone, a proximity sensor, a touch sensor, a gyroscope, a global positioning system (GPS) sensor, an ambient light sensor, a fingerprint sensor, a pedometer, a heart rate sensor, and a thermometer.

[0286] Embodiment 188. In the non-transitory computer-readable medium of any one of embodiments 152 to 187, the sensor includes a touch sensor, and the subject uses the touch sensor to provide compliance information to the electronic device.

[0287] Embodiment 189. In the non-transitory computer-readable media of embodiments 152 to 188, the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing a subject, viewing or editing personal information about the subject, viewing compliance information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic agent modules, prescribing one or more digital therapeutic agent modules to the subject, changing the prescription for one or more digital therapeutic agent modules, and communicating with the subject.

[0288] Embodiment 190. In the non-transitory computer readable medium of embodiment 189, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's guardian's email, a contact phone number for the subject, prescriptions for the subject, and one or more notes made by a healthcare provider for the subject.

[0289] Embodiment 191. In the non-transitory computer readable medium of embodiment 190, the personal information includes a prescription for the subject, the prescription for the subject including one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, a number of digital therapeutic modules scheduled or prescribed by the subject, and a number of digital therapeutic modules scheduled or prescribed by the subject per day.

[0290] Embodiment 192. In any one of the non-transitory computer-readable media of embodiments 189 to 191, one or more options include viewing adherence information, wherein the subject's adherence information includes one or more of the number of scheduled or prescribed digital therapeutic modules completed by the subject and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0291] Embodiment 193. In a non-transitory computer-readable medium of any one of embodiments 189 to embodiment 192, one or more options include viewing the subject's results, where the subject's results for one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapeutic module, the time the subject finished the scheduled or prescribed digital therapeutic module, an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI).

[0292] Embodiment 194. In the non-transitory computer-readable media of embodiments 152 to 193, the one or more options provided to a system administrator are selected from the group consisting of adding or removing a healthcare provider, viewing or editing personal information about a healthcare provider, viewing or editing de-identified information about a subject, viewing compliance information about a subject, viewing a subject's results for one or more at least partially completed digital therapeutic agent modules, and communicating with a healthcare provider.

[0293] Embodiment 195. In the non-transitory computer readable medium of embodiment 194, one or more options include viewing or editing personal information, and the personal information of the healthcare provider includes one or more selected from the group consisting of an identification number for the healthcare provider, the name of the healthcare provider, the email of the healthcare provider, and a contact phone number for the healthcare provider.

[0294] Embodiment 196. In the non-transitory computer-readable medium of embodiment 194 or embodiment 195, one or more options include viewing or editing the subject's de-identified information, wherein the subject's de-identified information includes one or more selected from the group consisting of an identification number for the subject and a health care provider for the subject.

[0295] Embodiment 197. In a non-transitory computer-readable medium of any one of embodiments 194 to 196, one or more options include viewing compliance information regarding the subject, the subject's compliance information including one or more of the number of scheduled or prescribed digital therapeutic modules completed by the subject and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0296] Embodiment 198. In a non-transitory computer-readable medium of any one of embodiments 194 to embodiment 197, one or more options include viewing the subject's results, and the subject's results for one or more at least partially completed digital therapeutic modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapeutic module, the time the subject finished the scheduled or prescribed digital therapeutic module, an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI).

[0297] Embodiment 199. In the non-transitory computer-readable medium of embodiments 152 to 198, the digital application further includes a push alarm for one or more of reminding the subject to complete the digital therapeutic agent module.

[0298] Embodiment 200. In the non-transitory computer-readable medium of embodiments 152 to 199, the digital device includes a digital task generation unit configured to generate a digital therapeutic agent module for treating cancer cachexia, generate a digital task based on the digital therapeutic agent module, and provide the digital task to a subject, and a result collection unit configured to collect results of the subject's execution of the digital task.

[0299] Embodiment 201. In the non-transitory computer-readable medium of embodiments 152 to 200, the digital problem generator generates a digital therapeutic agent module based on biochemical factors associated with the onset of cancer cachexia.

[0300] Embodiment 202. In the non-transitory computer readable medium of embodiment 201, the biochemical factors include insulin-like growth factor 1 (IGF1) and hypoxia-inducible factor 1 (HIF1).

[0301] Embodiment 203. In the non-transitory computer-readable medium of any of embodiments 152 to 202, the digital task generator generates a digital therapeutic agent module based on input from a healthcare provider.

[0302] Embodiment 204. In the non-transitory computer-readable medium of embodiments 152 to 203, the digital task generator generates a digital therapeutic module based on information received from the subject.

[0303] Embodiment 205. In the non-transitory computer-readable medium of embodiment 204, the information received from the subject includes at least one of the subject's baseline factors, medical information, and digital therapeutic agent comprehension capabilities, where the baseline factors include the subject's activity, heart rate, sleep, and diet (including nutrients and calories), the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerabilities and genetic susceptibilities, and the digital therapeutic agent comprehension capabilities include the subject's accessibility and technology adoption to digital therapeutics and devices.

[0304] Embodiment 206. In the non-transitory computer-readable medium of embodiments 152 to 205, the digital problem generator generates a digital therapeutic agent module that matches virtual parameters corresponding to a treatment hypothesis and mechanism of action for cancer cachexia.

[0305] Embodiment 207. In the non-transitory computer-readable medium of embodiment 206, the virtual parameters are inferred in relation to the subject's environment, behavior, emotions, and cognition.

[0306] Embodiment 208. In the non-transitory computer-readable media of embodiments 152 to 207, the result collection unit collects the results of the execution of the digital task by monitoring the subject's compliance with the digital task or by allowing the subject to directly input the subject's compliance with the digital task.

[0307] Embodiment 209. In the non-transitory computer-readable media of embodiments 152 to 208, the generation of digital tasks in the digital task generation unit and the collection of subject's execution results of the digital tasks in the result collection unit are performed multiple times in multiple feedback loops, and the digital task generation unit generates the subject's digital tasks for such cycle based on the subject's digital tasks in the previous cycle and the execution result data for the subject's digital tasks in the previous cycle collected by the result collection unit.

Claims

1. 1. A method of treating cancer cachexia in a subject in need thereof, comprising: providing the subject with one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module, by an electronic device, each of the one or more first modules including one or more first tasks to be followed by the subject; providing, to the subject, by the electronic device, one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module, the one or more second modules including one or more second tasks; The method, wherein the electronic device includes a sensor that senses compliance by the subject with the first task of the one or more first modules, transmits compliance information to a server based on the compliance, and receives one or more second tasks from the server based on the compliance information.

2. The method of claim 1, wherein the voluntary skeletal muscle movement module comprises one or more tasks for increasing MGF / IGF-1 secretion in the subject.

3. 2. The method of claim 1, wherein the one or more first modules include the vagus nerve stimulation module, the vagus nerve stimulation module including at least one task selected from the group consisting of sensory stimulation tasks for vision, hearing, touch, taste, and smell.

4. The method of claim 1 , wherein the one or more first modules include an aerobic exercise module, and the aerobic exercise module includes one or more first tasks for increasing adiponectin secretion in the subject.

5. The method of claim 1, wherein the one or more first modules include the relaxation module, and the relaxation module includes one or more first tasks for increasing adiponectin secretion in the subject.

6. The method of claim 1 , wherein the subject is a terminal cancer patient and the method excludes the step of providing a voluntary skeletal muscle motor module.

7. 10. The method of claim 1, wherein the sensors include one or more of a camera, an accelerometer, a magnetometer, a light sensor, a microphone, a proximity sensor, a touch sensor, a gyroscope, a Global Positioning System (GPS) sensor, an ambient light sensor, a fingerprint sensor, a pedometer, a heart rate sensor, and a thermometer.

8. The method of claim 1 , wherein the sensor comprises a touch sensor, and the subject provides the adherence information to the electronic device using the touch sensor.

9. 1. A system for treating cancer cachexia in a subject, comprising: a digital device configured to execute a digital application comprising one or more first modules for treating the cancer cachexia in the subject, the digital device comprising a sensor for sensing compliance of the subject with a first set of tasks of the one or more first modules; a healthcare provider portal configured to provide one or more options to a healthcare provider to take one or more actions to prescribe a treatment for the cancer cachexia for the subject based on the information received from the digital application; and an administration portal configured to provide one or more options to an administrator of the system to perform one or more actions to manage access to the system by the healthcare providers.

10. 10. The system of claim 9, wherein the digital device generates a digital therapeutic module based on biochemical factors associated with the cancer cachexia.

11. 10. The system of claim 9, wherein the digital application transmits data to a server, the server receiving one or more secondary challenges from an external reviewer.

12. 10. The system of claim 9, wherein the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing the subject, viewing or editing personal information about the subject, viewing compliance information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic modules, prescribing one or more digital therapeutic modules to the subject, changing a prescription for one or more digital therapeutic modules, and communicating with the subject.

13. 10. The system of claim 9, wherein the one or more options include viewing adherence information for the subject, the adherence information for the subject including one or more of: a number of scheduled or prescribed digital therapeutic modules completed by the subject, and a calendar identifying one or more dates on which the subject has completed, partially completed, or not completed one or more scheduled or prescribed digital therapeutic modules.

14. The information received from the subject includes at least one of the subject's baseline factors, medical information, or digital therapeutic comprehension ability; the baseline factors include the subject's activity, heart rate, sleep, and diet, including nutritional and caloric intake; the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerability, and genetic susceptibility; 10. The system of claim 9, wherein the digital therapeutic understanding capabilities include the subject's accessibility and technology adoption to the digital therapeutic and the device.

15. The system of claim 9, wherein the result collection unit collects results of the execution of the digital task by monitoring the subject's compliance with the digital task or by allowing the subject to directly input the subject's compliance with the digital task.

16. 1. A computing system for treating cancer cachexia from a subject in need thereof, comprising: a display configured to provide to the subject one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module, each of the one or more first modules including one or more first tasks for the subject to follow; a sensor configured to sense compliance by the subject with the tasks of the one or more first modules; a transmitter configured to transmit compliance information to a server based on the compliance; a receiver configured to receive one or more second challenges from the server based on the compliance information; The computing system, wherein the display is further configured to provide to the subject one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module, each of the one or more second modules including one or more second tasks.

17. 1. A non-transitory computer readable medium having stored thereon software instructions for treating cancer cachexia in a subject in need thereof, the software instructions, when executed by a processor, causing the processor to: displaying to the subject, by an electronic device, one or more first modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module, each of the one or more first modules including a task for the subject to follow; sensing compliance by the subject with the tasks of the one or more first modules using a sensor of the electronic device; transmitting compliance information to a server based on the compliance by the electronic device; receiving one or more second tasks from the server based on the compliance information; A non-transitory computer-readable medium, comprising: a computer-readable storage medium for storing a plurality of second modules including a first module and a second module for displaying to the subject one or more second modules selected from the group consisting of a voluntary skeletal muscle movement module, a vagus nerve stimulation module, an aerobic movement module, and a relaxation module, the one or more second modules including the one or more second tasks.

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