Head cooling device

Abstract

Provided are a head cooling device to be worn on a patient's head during administration of an anticancer drug, and a method for preventing hair loss using the same. [Solution] A head cooling device 100 that is worn on the head 10 of patient P during the administration of anticancer drugs, comprising an ice pack 1 contained in a sealed container and a cap 2 that covers the entire head 10 of patient P and secures the ice pack 1 to the head of patient P, wherein the ice pack 1 contains a mixed aqueous solution of 5.0 to 8.0 wt% salt and 20 to 27 wt% urea.

Description

[Technical Field]

[0001] The present invention relates to a head cooling device that is worn on a patient's head during administration of an anticancer drug, and a method for preventing hair loss using the same. [Background technology]

[0002] It is known that the administration of anticancer drugs in cancer treatment can cause side effects such as vomiting, nausea, loss of appetite, and severe hair loss. Because anticancer drugs are administered periodically and multiple times, once hair loss occurs due to side effects, it takes a long time for hair to grow back, which places a great mental burden on patients. In addition, damage to hair matrix cells in the scalp can cause changes in hair quality, making it difficult to restore the original hair texture.

[0003] One known method for preventing alopecia caused by anticancer drugs is to cool the head during administration of the anticancer drugs (for example, Patent Document 1, Non-Patent Document 1).

[0004] Patent document 1 discloses that a heat exchanger cap configured to conform to the human head cools the patient's head during chemotherapy, reducing the extent and likelihood of hair loss.

[0005] Non-Patent Document 1 discloses that a solution of 4% saline and disinfectant ethanol mixed in a 9:1 ratio is sealed in an infusion pack, frozen, and placed on the patient's head to cool the patient's head while an anticancer drug is being administered, thereby preventing hair loss. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Special Publication 2017-529155 [Non-patent literature]

[0007] [Non-Patent Document 1] Japanese Journal of Nursing Research Vol.19 No.1 1996 Attempt to prevent hair loss during anticancer drug administration Summary of the Invention [Problem to be solved by the invention]

[0008] However, cooling the head with the heat exchanger cap described in Patent Document 1 can cause discomfort such as chills and headaches (trigeminal neuralgia) due to excessive cooling, jaw pain due to wearing the cap, nausea, and a rubbery odor. Furthermore, when performing cooling therapy using this heat exchanger cap, costs are incurred for purchasing the scalp cooling cap and for using the cooling device. Such cooling therapy is not covered by insurance and is fully self-paid, posing a significant financial burden for patients.

[0009] Furthermore, since anticancer drugs are usually administered repeatedly at regular intervals, the ice packs used in cryotherapy must be durable. However, the ice pack described in Non-Patent Document 1 contains alcohol, and therefore its composition is prone to change. Furthermore, the alcohol component contained in the ice pack may dissolve the container, causing the ice pack to leak out of the container.

[0010] Therefore, an object of the present invention is to provide a head cooling device that is worn on a patient's head during administration of an anticancer drug, and a method for preventing hair loss using the same. [Means for solving the problem]

[0011] In order to solve the above problems, the head cooling device of the present invention is a head cooling device that is worn on a patient's head during the administration of anticancer drugs, and is composed of an ice pack contained in a sealed container and a cap that covers the entire patient's head and secures the ice pack to the patient's head, and the ice pack contains a mixed aqueous solution of 5.0 to 8.0 wt% salt and 20 to 27 wt% urea.

[0012] According to the above configuration, the ice pack contains a mixed aqueous solution of 5.0 to 8.0 wt. % salt and 20 to 27 wt. % urea, which allows the ice pack to maintain appropriate fluidity after cryopreservation and maintain the patient's scalp at an appropriate temperature for the time required for anticancer drug administration. As a result, blood flow to the patient's scalp can be suppressed, preventing hair loss. Furthermore, because the ice pack does not contain volatile substances and is unlikely to change in composition, it can be reused after each chemotherapy treatment.

[0013] The head cooling device of the present invention may further include a belt for compressing at least one of the patient's forehead, occipital region, left head, right head, and parietal region.

[0014] According to the above configuration, by compressing the patient's head, blood flow to the scalp can be further suppressed.

[0015] In the head cooling device of the present invention, the sealed container may have a length of 13 to 30 cm, a width of 12 to 20 cm, and a thickness of 0.07 to 0.15 mm.

[0016] According to the above configuration, the heat of the ice pack is efficiently conducted to the patient's head, thereby further suppressing blood flow to the scalp.

[0017] In the head cooling device of the present invention, the sealed container may contain 180 to 400 mL of the ice pack.

[0018] According to the above configuration, the ice pack contained in the sealed container has a shape that makes it easier for it to fit closely to the patient's head, so that the scalp can be kept at a more appropriate temperature.

[0019] In order to solve the above problems, the hair loss prevention method of the present invention is a method for preventing hair loss using any one of the head cooling devices described above, and includes a freezing step of putting the ice pack in a freezer at -15 to -25°C and freezing it for 24 hours or more, a contact step of making the ice pack frozen in the freezer fit tightly to the patient's head, a wearing step of covering the entire patient's head with the cap and fixing and wearing the ice pack on the patient's head, and a head cooling step of maintaining the temperature of the patient's head at 17 to 25°C for 30 to 90 minutes.

[0020] According to the above configuration, the ice pack can maintain appropriate fluidity after cryopreservation and can maintain the patient's scalp at an appropriate temperature for the time required for anticancer drug administration. As a result, blood flow to the patient's scalp can be suppressed, preventing hair loss. Furthermore, since the ice pack does not contain volatile substances and its composition is unlikely to change, it can be used repeatedly after each chemotherapy treatment. [Effects of the Invention]

[0021] According to the present invention, the ice pack after cryopreservation can maintain appropriate fluidity and can keep the patient's scalp at an appropriate temperature for the time required for the administration of anticancer drugs. As a result, hair loss can be prevented. Furthermore, since the ice pack does not contain volatile substances and its composition is unlikely to change, it can be used repeatedly after each chemotherapy treatment. [Brief explanation of the drawings]

[0022] [Figure 1] 1 is a front cross-sectional view showing a schematic configuration of a head cooling device according to the present invention. [Figure 2] 1 is a side cross-sectional view showing a schematic configuration of a head cooling device according to the present invention. [Figure 3] 1 is a front view showing a state in which the head cooling device according to the present invention is used. [Figure 4] 1 is a side view showing a state in which the head cooling device according to the present invention is used. DETAILED DESCRIPTION OF THE INVENTION

[0023] The following describes in detail the embodiments and drawings relating to the head cooling device and the hair loss prevention method using the same according to the present invention. However, the present invention is not intended to be limited to the configurations shown in the embodiments and drawings described below.

[0024] (head cooling device) Fig. 1 is a front cross-sectional view showing the schematic configuration of a head cooling device according to the present invention. Fig. 2 is a side cross-sectional view showing the schematic configuration of a head cooling device according to the present invention. As shown in Figs. 1 and 2, head cooling device 100 is composed of an ice pack 1 contained in an airtight container and a cap 2 that covers the entire head 10 of patient P and secures ice pack 1 to head 10 of patient P. When worn on head 10 of patient P during administration of an anticancer drug, head cooling device 100 can suppress blood flow to the scalp of patient P and prevent hair loss.

[0025] (Ice packs) Ice pack 1 contains a mixed aqueous solution of 5.0 to 8.0 wt % salt and 20 to 27 wt % urea. Ice pack 1 is the mixed aqueous solution contained in a sealed container. When ice pack 1 is stored in a household freezer (set temperature: -15 to -25°C) for 24 hours or more, ice pack 1 maintains appropriate fluidity for a certain period of time. This allows ice pack 1 to be attached closely to patient P's head 10. Furthermore, by maintaining patient P's head 10 at an appropriate temperature (approximately 19°C) for the time required for anticancer drug administration, it is possible to prevent patient P from experiencing physical discomfort such as chills or headaches due to excessive cooling, while also preventing hair loss. Furthermore, ice pack 1 does not contain any volatile substances and is unlikely to change in composition, allowing it to be reused after each chemotherapy treatment.

[0026] (cap) FIG. 3 is a front view showing the head cooling device according to the present invention in use. FIG. 4 is a side view showing the head cooling device according to the present invention in use. As shown in FIGS. 1 to 4, the cap 2 is used to secure and attach the ice pack 1 to the head 10 of the patient P. The cap 2 may be shaped to cover the entire head 10 of the patient P (the forehead, back of the head, left head, right head, and parietal area). The material of the cap 2 is preferably a water-absorbent material. The material of the cap 2 preferably contains cotton if it is a plant fiber, or preferably contains rayon or polyester if it is a chemical fiber, or may contain a combination of these. Although not shown, a pocket may be provided inside the cap 2, and the ice pack 1 may be inserted into the pocket and be attached to the head 10 via the pocket. In this case, the pocket is preferably made of a mesh material so as not to inhibit heat conduction from the ice pack 1 to the head 10.

[0027] (belt) The belt 3 compresses at least one of the frontal, occipital, left and right temporal regions, and parietal regions of the patient P. The belt 3 is preferably made of a stretchable material and is preferably detachable with a hook-and-loop fastener 31, but the head may also be compressed by tightly wrapping a bandage or a large piece of fabric around the head 10. As shown in FIGS. 1 to 4, the belt 3 may be worn around the parietal and chin regions of the head 10, compressing the parietal region of the patient P. Furthermore, although not shown, the belt 3 may be worn from the frontal to the occipital regions of the head 10, compressing the frontal, temporal, and occipital regions.

[0028] (sealed container) The ice pack 1 is contained in a sealed container. The dimensions of the sealed container are preferably 13 to 30 cm in length and 12 to 20 cm in width. The thickness of the sealed container is also preferably 0.07 to 0.15 mm. When the sealed container for the ice pack 1 is configured in this way, the heat of the ice pack 1 is efficiently conducted to the head 10 of the patient P, thereby further suppressing blood flow to the scalp. The sealed container may be a container with a single layer structure made of polyethylene (PE), but from the viewpoint of durability, it is preferable that it be a container with a multi-layer structure made of, for example, polyethylene (PE), a nylon film (NY), and a linear low-density polyethylene film (LL).

[0029] The sealed container preferably contains 180 to 400 mL of ice packs. The ice packs 1a and 1b to be attached to the forehead and back of the head are preferably contained in a sealed container at 320 to 390 mL. The ice packs 1c and 1d to be attached to the left and right head are preferably contained in a sealed container at 200 to 300 mL. The ice packs 1 (1a to 1d) are attached to each position on the head 10 of the patient P, thereby maintaining the scalp at a more appropriate temperature. While Figures 1 and 2 show a head cooling device 100 composed of four ice packs to be attached to the forehead, back of the head, left head, and right head, it may also be composed of three ice packs to be attached to the top of the head, left head, and right head, for example.

[0030] (How to prevent hair loss) The hair loss prevention method using the head cooling device of the present invention includes a freezing step of placing the above-mentioned ice pack 1 in a freezer at -15 to -25°C and freezing it for 24 hours or more, a contact step of making the ice pack 1 frozen in the freezer fit tightly to the head 10 of patient P, a fitting step of covering the entire head 10 of patient P with cap 2 and fixing and fitting the ice pack 1 to the head 10 of patient P, and a head cooling step of maintaining the temperature of the head 10 of patient P at 17 to 25°C for 30 to 90 minutes.

[0031] (Freezing process) In the freezing process, ice pack 1 is stored in a freezer at -15 to -25°C, preferably -18 to -20°C, for 24 hours or more. Ice pack 1 stored in the freezer can be used for head cooling during anticancer drug administration if it is removed from the freezer and placed in an insulated bag or cooler box within 60 minutes. Therefore, the patient P can bring ice pack 1 frozen in a household freezer at home to the hospital and independently perform head cooling. Furthermore, if the travel time from patient P's home to the hospital exceeds 60 minutes, ice pack 1 can be refrozen for 90 minutes or more in the hospital freezer before being used for head cooling.

[0032] (Adhesion process) In the contacting step, ice packs 1 frozen in a freezer are brought into close contact with the patient's head. As shown in FIGS. 1 and 2, ice pack 1a is brought into close contact with the forehead, ice pack 1b with the back of the head, ice pack 1c with the left head, and ice pack 1d with the right head. The sealed container preferably contains 180 to 400 mL of ice packs. The ice packs 1a and 1b that are brought into close contact with the forehead and back of the head are preferably contained in a sealed container with a volume of 320 to 390 mL. The ice packs 1c and 1d that are brought into close contact with the left head and right head are preferably contained in a sealed container with a volume of 200 to 300 mL. The ice packs 1 (1a to 1d) are brought into close contact with each position on the patient P's head 10, thereby maintaining the scalp at a more appropriate temperature.

[0033] (Installation process) In the wearing step, the cap 2 covers the entire head 10 of the patient P, and the ice pack 1 is fixed and worn on the head 10 of the patient P. The cap 2 is used to fix and wear the ice pack 1 on the head 10 of the patient P. The cap 2 may be shaped to cover the entire head 10 of the patient P (forehead, back of the head, left head, right head, and parietal area). The material of the cap 2 is preferably water-absorbent. The material of the cap 2 preferably contains cotton if it is a plant fiber, and preferably contains rayon or polyester if it is a chemical fiber, or may contain a combination of these. Although not shown, a pocket may be provided inside the cap 2, and the ice pack 1 may be inserted into the pocket and attached to the head 10 via the pocket. In this case, the pocket is preferably made of a mesh material so as not to inhibit heat conduction from the ice pack 1 to the head 10.

[0034] Furthermore, in the wearing step, the belt 3 may compress at least one of the frontal, occipital, left and right temporal regions, and parietal region of the patient P. The belt 3 is preferably made of a stretchable material and is preferably attachable and detachable with a hook-and-loop fastener 31, but the head may also be compressed by tightly wrapping a bandage or a large piece of fabric around the head 10. As shown in FIGS. 1 to 4, the belt 3 may be worn around the parietal and chin region of the head 10 so that the parietal region of the patient P is compressed. Furthermore, although not shown, the belt 3 may be worn from the frontal to occipital region of the head 10 so that the frontal, temporal, and occipital regions are compressed.

[0035] (head cooling process) In the head cooling process, the head 10 of the patient P is maintained at a temperature of 17 to 25°C for 30 to 90 minutes. In the head cooling process, the scalp of the patient P can be kept at an appropriate temperature (about 19°C) for the time required for administering the anticancer drug, so that the patient P can be prevented from suffering from physical discomfort such as chills or headaches due to excessive cooling, and hair loss can be prevented. [Example]

[0036] The inventors have investigated ice packs that can stably maintain the temperature of a patient's scalp at an appropriate temperature for a certain period of time. Specifically, the following tests were conducted to verify the sustained cooling effect of the present embodiment.

[0037] (Test Example 1) Subject A (a female breast cancer patient in her 50s) received weekly anticancer drug treatments. The first time, paclitaxel, Perjeda, and Herceptin (registered trademark) were administered. The second and third times, paclitaxel was administered. However, due to an allergic reaction, paclitaxel was discontinued, and from the fourth time onwards, only Perjeda and Herceptin were administered. During this chemotherapy, the scalp was not cooled, resulting in most of the hair falling out.

[0038] (Test Example 2) Subject A received weekly anticancer drug administration. The first administration consisted of Halaven®, Perjeda®, and Herceptin®. From the second administration onward, Halaven® was administered. Scalp cooling was not performed during the first and second administrations. From the third administration onward, scalp cooling was performed. During the third and fourth administrations, the head was cooled using a commercially available ice pack (Cramer Cold / Hot pack, 10 cm x 25 cm) that had been frozen in a home freezer for at least 24 hours. Specifically, a cloth (53 cm x 53 cm, 100% cotton) and a Velcro strap were used to compress the scalp's nutrient vessels, including the occipital artery, superficial temporal artery, and frontal artery. The ice pack was then placed on the head and secured in place by wrapping cotton around the head. When using commercially available ice packs, the head did not cool for an adequate period of time. Therefore, for the fifth and subsequent anticancer drug administrations, a mixture of 4% saline solution by weight and rubbing alcohol in an 8:2 ratio was sealed in a commercially available polyethylene airtight container and used as ice pack A. To cool the left and right temporal regions, two 350 mL polyethylene airtight freezer containers (Kohnan Shoji Co., Ltd., 29 cm x 12 cm, 0.07 mm thick) were prepared. To cool the vertex, one 400 mL polyethylene airtight freezer container (Kohnan Shoji Co., Ltd., 20 cm x 18 cm, 0.07 mm thick) was prepared. Each ice pack, which had been frozen in a household freezer for at least 24 hours, was placed tightly against Subject A's left and right temporal regions and the vertex and secured in place with a cap. No hair loss was observed after anticancer drug administration.

[0039] (Test Example 3) Because differences were observed in the cooling effect of the commercially available ice pack (Cramer Cold / Hot pack) and Ice Pack A, the temperature changes of these ice packs were examined. Each ice pack, which had been stored in a freezer at -18°C for more than 24 hours, was placed on a 100% cotton terry cloth, and the temperature change between each ice pack and the terry cloth was measured using a digital thermometer. Table 1 shows the results of Test Example 3.

[0040] [Table 1]

[0041] As shown in Table 1, it was found that ice pack A, which was a mixture of 4% by weight saline solution and rubbing alcohol in an 8:2 ratio, had a longer-lasting cooling effect than commercially available ice packs.

[0042] However, although ice pack A provides long-lasting cooling and sufficient head cooling effect, the alcohol contained in ice pack A may react with the sealed plastic container that holds it, changing the composition of the ice pack or dissolving the sealed container, which may result in leakage of the ice pack. Anticancer drug administration is typically repeated at regular intervals, so durability of the ice pack is essential. Therefore, the present inventors conducted the following study on alcohol-free ice packs.

[0043] (Test Example 4) Urea was added to 4%, 7%, and 10% saline solutions to make 12.5% ​​and 25% by weight of each mixed aqueous solution, respectively. 200 mL of each solution was sealed in a polyethylene airtight container for freezing storage (Kohnan Shoji Co., Ltd., 15 cm long x 20 cm wide, 0.07 mm thick) and stored in a freezer at -18°C for at least 24 hours. The condition of each ice pack was then checked. Table 2 shows the results of Test Example 4.

[0044] [Table 2]

[0045] As shown in Table 2, ice packs D, F, and G were found to be flexible after freezing. On the other hand, ice packs B, C, and E were frozen solid after freezing and showed no flexibility.

[0046] (Test Example 5) Next, the temperature change after freezing was measured for ice packs D, F, and G. As in Test Example 3 above, each ice pack that had been stored in a freezer at -18°C for 24 hours or more was placed on a 100% cotton towel cloth, and the temperature change between each ice pack and the towel cloth was measured using a digital thermometer. Table 3 shows the results of Test Example 5.

[0047] [Table 3]

[0048] As shown in Table 3, it was revealed that ice pack F, which contained a mixed aqueous solution of 7 wt % salt and 25 wt % urea, had the highest cooling effect.

[0049] (Test Example 6) The following study was conducted to determine whether adding urea to ice pack F would improve its cooling effect. A 200 mL solution containing a 7 wt. % salt and 30 wt. % urea mixture was sealed in a polyethylene airtight container (Kohnan Shoji Co., Ltd., 15 cm x 20 cm, 0.07 mm thick) for freezing. Ice pack H was newly prepared and stored in a -18°C freezer for at least 24 hours. After storage, a comparison was made with ice pack F. As in Test Example 3 above, each ice pack stored in a -18°C freezer for at least 24 hours was placed on a 100% cotton towel cloth, and the temperature change between each ice pack and the towel cloth was measured using a digital thermometer. Table 4 shows the results of Test Example 6.

[0050] [Table 4]

[0051] As shown in Table 4, it was clear that ice pack F had a higher cooling effect than ice pack H. In other words, adding more urea to ice pack F did not improve the cooling effect.

[0052] As a result of the above investigation, it was found that ice pack F, which contains a mixed aqueous solution of 7% by weight of salt and 25% by weight of urea, had the highest cooling effect.

[0053] (Test Example 7) Subject B (female, in her 40s) was asked to wear a head cooling device using ice pack F, and it was confirmed whether wearing the device caused any discomfort such as chills or headaches. First, ice packs for cooling the forehead and back of the head were prepared. 340 mL of a mixed aqueous solution of 7 wt% salt and 25 wt% urea was placed in each of two polyethylene containers (Alfor International, 18.5 cm long x 14-16 cm wide, 0.1 mm thick). The containers were sealed by heat welding and stored in a -18°C freezer for 16 hours. Next, ice packs for cooling the left and right temporal regions were prepared. Two polyethylene containers (Alfor International, 15 cm long x 19.5 cm wide, 0.1 mm thick) were filled with 260 mL of a mixed aqueous solution of 7% by weight salt and 25% by weight urea, and the containers were sealed by heat welding and stored in a -18°C freezer for 16 hours. Each ice pack was taken out of the freezer and placed firmly on the front, back, left and right sides of Subject B's head, and the entire head was covered with a cap to secure each ice pack to Subject B's head. At this time, a magic belt was attached around the top of Subject B's head and chin to apply pressure to the top of Subject B's head. Here, four multi-function digital thermometers were used to measure the temperatures of the subject's forehead, occipital, left and right head. To prevent the thermometer sensor from directly contacting the ice pack, the scalp temperature was measured by separating the sensor area with an aluminum foil urethane sheet. Table 5 shows the results of Test Example 7.

[0054] [Table 5]

[0055] (Test Example 8) In Test Example 8, the test was carried out in the same manner as in Test Example 7, except that the sample was stored in a freezer at −18° C. for 24 hours. Table 6 shows the results of Test Example 8.

[0056] [Table 6]

[0057] As shown in Table 5, ice pack F stored in a -18°C freezer for 16 hours maintained the scalp temperature of subject B at 17.6 to 31.1°C. Also, as shown in Table 6, ice pack F stored in a -18°C freezer for 24 hours maintained the scalp temperature of subject B at 17.1 to 24.8°C. Furthermore, according to Subject B, in both Test Examples 7 and 8, the entire scalp felt cold, but no headaches, chills, or other physical discomfort or frostbite occurred. Since it is necessary to maintain the scalp temperature at around 19°C for a certain period of time to prevent hair loss during the administration of anticancer drugs, it became clear that it is desirable to store Ice Pack F in a freezer at -18°C for 24 hours or more.

[0058] From the above results, it became clear that storing ice pack F, which contains a mixed aqueous solution of 7% by weight salt and 25% by weight urea, in a freezer at -18°C for 24 hours has a greater head cooling effect than storing it for 16 hours.

[0059] (Test Example 9) Furthermore, tests were conducted on other subjects C, D, and E to determine whether cooling the head with an ice pack would cause frostbite on the scalp. The ice pack used in Test Example 9 was ice pack F, which had been stored in a freezer at -18°C for 24 hours, as in Test Example 8. Tables 7 to 9 show the results of Test Example 9.

[0060] [Table 7]

[0061] According to subject C, while wearing the head cooling device, his scalp felt cold, but it was not painful and felt good. After the test, he did not experience any frostbite or headaches, and his scalp was in good condition.

[0062] [Table 8]

[0063] According to Subject D, while wearing the head cooling device, his scalp felt cool, but not too cold, and the back of his head felt the coldest. After the test, he had no frostbite or headaches, and his scalp was in good condition.

[0064] [Table 9]

[0065] According to Subject E, wearing the head cooling device was limited to 30 minutes. He seemed tired from the weight of the device. While wearing the head cooling device, he did not feel too cold, and after the test, he did not suffer from frostbite or headaches, and his scalp was in good condition. The reason why no temperature measurement was obtained on the right side of the head in Table 9 was due to a malfunction of the thermometer.

[0066] As described above, in Test Example 9, subjects C, D, and E did not experience frostbite on the scalp, and no major side effects were caused by head cooling. In addition, in subject E (a 6-year-old boy (first grade of elementary school)), the weight of the ice pack placed a strain on his head. Therefore, when cooling a child's scalp, it is expected that the scalp can be cooled for a longer period of time and more stably by adjusting the volume of the ice pack and the dimensions of the airtight container.

[0067] (Test Example 10) We investigated airtight containers for storing ice packs. Two airtight containers were used: a single-layer container made of polyethylene (PE) (Alfor International Co., Ltd., 18.5 cm long x 14-16 cm wide, 0.1 mm thick) (hereafter referred to as airtight container I), and a three-layer container made of nylon film (NY), polyethylene (PE), and linear low-density polyethylene film (LL) (Star Plastics Industrial Co., Ltd., Eslap AL NY / PE / LL, 18 cm long x 15 cm wide, 0.08 mm thick) (hereafter referred to as airtight container II). Each container was filled with 400 mL of a mixed aqueous solution of 7% by weight salt and 25% by weight urea, the same composition as ice pack F used in Test Examples 5 to 9, and the container was sealed by heat sealing. After storing in a -18°C freezer for at least 48 hours, each ice pack was removed from the freezer and placed on a 100% cotton towel cloth. The temperature change between each ice pack and the towel cloth was measured using a digital thermometer. Table 10 shows the results of Test Example 10.

[0068] [Table 10]

[0069] It was found that the ice pack sealed in sealed container II maintained its cooling effect for a longer period of time than the ice pack sealed in sealed container I. This is presumably due to the difference in the thickness of the sealed container. While subject A was receiving anticancer drugs, the scalp was kept cool using an ice pack sealed in a 0.07 mm thick polyethylene sealed container. However, the ice pack could not withstand repeated freezing and leaked. Therefore, a test was conducted using the stronger 0.1 mm thick polyethylene sealed container I, and it was found to be able to withstand repeated freezing almost completely. Therefore, it was found that while the 0.1 mm thick sealed container I is preferable as a sealed container for ice packs, the 0.08 mm thick multi-layered sealed container II is more preferable.

[0070] (Test Example 11) Assuming that a patient would bring an ice pack frozen in their home freezer to the hospital and wear a head cooler to cool their head independently during chemotherapy administration, we investigated how to transport the ice pack while maintaining its temperature. Ice pack F was created by placing 260 mL of a mixed aqueous solution containing 7% sodium chloride and 25% urea in each of two airtight polyethylene freezer containers (Alfor International Co., Ltd., 15 cm long x 19.5 cm wide, 0.1 mm thick) and sealing them by heat welding. One container was covered with bubble wrap and stored in an aluminum cooler bag, while the other was stored in an aluminum cooler bag without the bubble wrap. Temperature changes in each container were monitored. Table 11 shows the results of Test Example 11.

[0071] [Table 11]

[0072] It has been found that storing ice packs covered in bubble wrap can help keep the ice packs cooler.

[0073] (Test Example 12) We further investigated the composition of ice packs, assuming that patients would bring ice packs frozen in their own home freezers to the hospital and attach the head cooling device to their heads during anticancer drug administration to cool their heads independently. In Test Example 12, it was assumed that the patient's travel time to the hospital was 90 minutes, and that after arriving at the hospital, the ice pack was refrozen for 90 minutes or more inside the hospital and then used to cool the patient's head.

[0074] First, ice packs F, I, and J were prepared by adding urea to 7% saline to make 25%, 20%, and 15% urea, respectively. 500 mL of each was sealed in a polyethylene airtight container for freezing (Kohnan Shoji Co., Ltd., 18 cm wide x 20 cm long, 0.07 mm thick). The containers were then stored in a -18°C freezer for at least 48 hours. The temperature change of each ice pack after removal from the freezer was measured. Each frozen ice pack was placed on a 100% cotton towel cloth, and the temperature change between the ice pack and the towel cloth was measured using a digital thermometer. Table 12 shows the results of Test Example 12.

[0075] [Table 12]

[0076] Ice pack F was in a liquid state 60 minutes after being removed from the freezer. Ice pack I was in a state where a thin layer of ice was present 60 minutes after being removed from the freezer. Ice pack J was in a sherbet state 60 minutes after being removed from the freezer.

[0077] (Test Example 13) Next, ice packs F, I, and J were removed from the freezer and then stored in a -18°C freezer for 2 hours for refrozen storage approximately 90 minutes later. The temperature change of each ice pack after removal from the freezer was measured. Each refrozen ice pack was placed on a 100% cotton towel cloth, and the temperature change between each ice pack and the towel cloth was measured using a digital thermometer. Table 13 shows the results of Test Example 13.

[0078] [Table 13]

[0079] It was found that ice pack F maintained its cooling time the longest after refrozen and had the smallest temperature change. However, because ice pack F quickly turned into a liquid, there was concern that gravity would make it difficult to cool the top of the head. Therefore, further investigation was conducted into the composition of the ice packs.

[0080] (Test Example 14) Ice pack K, made by adding urea to 5% saline solution to make 20% urea; ice pack L, made by adding urea to 6% saline solution to make 20% urea; and ice pack M, made by adding urea to 7% saline solution to make 20% urea. 500 mL of each was sealed in a polyethylene airtight container for freezing storage (Kohnan Shoji Co., Ltd., 18 cm wide x 20 cm long x 0.07 mm thick). Stored in a -18°C freezer for at least 48 hours, the temperature change of each ice pack was measured after removal from the freezer. Each frozen ice pack was placed on 100% cotton terry cloth, and the temperature change between each ice pack and the terry cloth was measured using a digital thermometer. Table 14 shows the results of Test Example 14.

[0081] [Table 14]

[0082] Sixty minutes after being removed from the freezer, ice packs K and L were in a state of thin ice. Sixty minutes after being removed from the freezer, ice pack M was in a liquid state.

[0083] (Test Example 15) Ice pack N, made by adding urea to 5% saline solution to make 25% urea; ice pack O, made by adding urea to 6% saline solution to make 25% urea; and ice pack F, made by adding urea to 7% saline solution to make 25% urea. 500 mL of each was sealed in a polyethylene airtight container for freezing storage (Kohnan Shoji Co., Ltd., 18 cm wide, 20 cm long, 0.07 mm thick). Stored in a -18°C freezer for at least 48 hours, the temperature change of each ice pack was measured after removal from the freezer. Each frozen ice pack was placed on 100% cotton terry cloth, and the temperature change between each ice pack and the terry cloth was measured using a digital thermometer. Table 15 shows the results of Test Example 15.

[0084] [Table 15]

[0085] 60 minutes after being removed from the freezer, ice packs N and O were in a state of sherbet-like lumps. 60 minutes after being removed from the freezer, ice pack F was in a liquid state.

[0086] The results of Test Examples 13 and 14 revealed that ice pack O, which contained 25% urea and 6% salt, provided the longest cooling duration. Also, ice pack N, which contained 25% urea and 5% salt, had not completely melted even 60 minutes after the start of the test, demonstrating that it provided good conditions for cooling the head over time.

[0087] (Test Example 16) Ice pack N, made by adding urea to 5% saline solution to make 25% urea; ice pack O, made by adding urea to 6% saline solution to make 25% urea; and ice pack P, made by adding urea to 5.5% saline solution to make 25% urea. 500 mL of each was sealed in a polyethylene airtight container for freezing (Kohnan Shoji Co., Ltd., 18 cm wide x 20 cm long x 0.07 mm thick). Stored in a -18°C freezer for at least 48 hours, the temperature change and condition of each ice pack were monitored after removal from the freezer. Each frozen ice pack was placed on 100% cotton terry cloth, and the temperature change between the ice pack and the terry cloth was measured using a digital thermometer. Table 16 shows the results of Test Example 16.

[0088] [Table 16]

[0089] Ice pack N was completely frozen for 10 minutes after being taken out of the freezer. After 20 minutes, it was completely frozen, but there was still a small amount of liquid. Immediately after being taken out of the freezer, the ice pack P was completely frozen. After 10 to 20 minutes, it was completely frozen, but still contained a small amount of liquid. Immediately after taking ice pack O out of the freezer, it was frozen overall, but there was also a small amount of liquid. After 10 minutes, the frozen and liquid parts were in equal proportions. It was found that ice packs N and P remained frozen for a longer period of time than ice pack O, and maintained their cooling properties for a longer period of time.

[0090] (Test Example 17) For ice packs N and P, 60 minutes after removal from the freezer, they were stored in a -18°C freezer for 90 minutes to refrozen, and the temperatures were measured after removal from the freezer. Each refrozen ice pack was placed on a 100% cotton towel cloth, and the temperature change between each ice pack and the towel cloth was measured using a digital thermometer. Table 17 shows the results of Test Example 17.

[0091] [Table 17]

[0092] After refrozen, both ice packs N and P were frozen completely immediately after removal from the freezer, but there was still a small amount of liquid. After 10 and 20 minutes, the temperature of ice pack P was maintained at a slightly lower temperature than ice pack N.

[0093] (Test Example 18) Based on the above experimental results, scalp temperature was measured using ice pack P containing a mixed aqueous solution of 5.5 wt % salt and 25 wt % urea. Subject B (female, in her 40s) was asked to wear a head cooling device using ice pack P, and it was confirmed whether wearing the device caused any discomfort such as chills or headaches. First, ice packs for cooling the forehead and back of the head were prepared. 380 mL of a mixed aqueous solution of 5.5 wt% salt and 25 wt% urea was placed in each of two polyethylene airtight containers for freezing (Alfor International, 18.5 cm long x 14-16 cm wide, 0.1 mm thick), which were then sealed by heat welding and stored in a -18°C freezer for at least 48 hours. Next, ice packs for cooling the left and right temporal regions were prepared. 290 mL of a mixed aqueous solution of 5.5% by weight salt and 25% by weight urea was placed in each of two polyethylene airtight containers for freezing (Alfor International, 15 cm long x 19.5 cm wide, 0.1 mm thick), which were then sealed by heat welding and stored in a -18°C freezer for at least 48 hours. Each ice pack was taken out of the freezer and placed firmly on the front, back, left and right sides of Subject B's head, and the entire head was covered with a cap to secure each ice pack to Subject B's head. At this time, a magic belt was attached around the top of Subject B's head and chin to apply pressure to the top of Subject B's head. Here, four multi-function digital thermometers were used to measure the temperatures of the subject's forehead, occipital, left and right head. To prevent the thermometer sensor from directly contacting the ice pack, the scalp temperature was measured by separating the sensor area with an aluminum foil urethane sheet. Table 18 shows the results of Test Example 18.

[0094] [Table 18]

[0095] As shown in Table 18, the scalp of subject B was kept at 15.8 to 24.3°C by ice pack P stored in a freezer at -18°C for 48 hours. Furthermore, subject B said that he felt a strong chill all over his scalp, but he did not experience any headaches, chills, or other physical discomfort, nor did he suffer from frostbite. The reason why no temperature measurements were obtained for the back of the head in Table 18 was due to a malfunction of the thermometer.

[0096] (Test Example 19) Furthermore, another subject A was tested to determine whether head cooling with ice pack P would cause frostbite on the scalp. In Test Example 19, the ice pack P used in Test Example 18 was used. After the experiment in Test Example 18 was completed, the ice packs P were stored in a freezer at -18°C for 24 hours, and each ice pack was fixed to the forehead, occipital region, left temporal region, and right temporal region of subject A and worn in the same manner as in Test Example 18. Table 19 shows the results of Test Example 19.

[0097] [Table 19]

[0098] As shown in Table 19, the scalp of subject B was kept at 17.3 to 24.7°C by ice pack P stored in a freezer at -18°C for 24 hours. Furthermore, subject A said that although he felt that his entire scalp was thoroughly cooled, he did not experience any headaches, chills, or other physical discomfort, nor did he suffer from frostbite. There were concerns that increasing the amount of ice pack would significantly increase the strain on the neck, but by reclining the chair to a moderate angle, placing a cushion around the neck, and keeping the head in a comfortable position, he did not feel any strain on the neck.

[0099] Based on all experimental results, it was found that a sufficient head cooling effect can be achieved when the ice pack contains a mixed aqueous solution of 5.0 to 8.0 wt% salt and 20 to 27 wt% urea. Furthermore, when patients bring ice packs frozen in their own home freezer to the hospital and refreeze them in the hospital freezer, it was found that the ice pack preferably contains a mixed aqueous solution of 5.5 wt% salt and 25 wt% urea. It was found that the sealed container preferably holds 180 to 400 mL of ice pack, and that the ice packs to be applied to the forehead and occipital regions preferably hold 320 to 390 mL, with 380 mL being more preferred. It was also found that the ice packs to be applied to the left and right temporal regions preferably hold 200 to 300 mL, with 290 mL being more preferred. [Industrial Applicability]

[0100] The head cooling device of the present invention and the method for preventing hair loss using the same can be used to prevent hair loss in patients receiving anticancer drugs. [Explanation of symbols]

[0101] 1, 1a, 1b, 1c, 1d: Ice packs 2: Cap 3: Belt 31: Velcro 10:Head 100: Head cooler P:Patient

Claims

1. A head cooling device that is worn on a patient's head during administration of an anticancer drug, A cooling agent contained in a sealed container; a cap that covers the patient's entire head and fixes the ice pack to the patient's head, The ice pack contains a mixed aqueous solution of 5.0 to 8.0 wt % salt and 20 to 27 wt % urea. Head cooling device.

2. The head cooling device according to claim 1 or 2, The head cooling device includes a belt for compressing at least one of the frontal, occipital, left temporal, right temporal, and parietal regions of the patient's head.

3. The head cooling device according to claim 1 or 2, The head cooling device has a sealed container having a length of 13 to 30 cm, a width of 12 to 20 cm, and a thickness of 0.07 to 0.15 mm.

4. The head cooling device according to claim 3, The airtight container is a head cooling device that contains 180 to 400 mL of the ice pack.

5. A method for preventing hair loss using the head cooling device according to claim 1 or 2, a freezing step of placing the ice pack in a freezer at −15 to −25° C. and freezing for 24 hours or more; a contact step of contacting the ice pack frozen in the freezer with the patient's head; a wearing step of covering the patient's entire head with the cap and fixing and wearing the ice pack on the patient's head; a head cooling step of maintaining the patient's head at a temperature of 17 to 25°C for 30 to 90 minutes; A method for preventing hair loss, comprising:

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