Treatment and prophylaxis of radiation dermatitis

a radiation dermatitis and treatment technology, applied in the direction of peptide/protein ingredients, drug compositions, aerosol delivery, etc., can solve the problems of limited use in non-malignant conditions, high risk of radiation-induced cancer, and present with desquamation or blistering, etc., to reduce the likelihood and facilitate the use of patients

Inactive Publication Date: 2018-09-20
SAFEGUARD MEDICAL HOLDCO LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0017]Advantageously, a formulation comprising purified water, thickener and milk protein fluid can be modified to provide various thicknesses of topical treatment. For example, a thick viscous formulation to sit on the skin following treatment with radiation will absorb heat whilst permitting application to a discrete area. Furthermore, the milk protein fluid can be applied to the area of radiation without being wasted on “non-damaged” areas. Alternatively for example, a less viscous formulation that can be more readily absorbed by the skin to provide ongoing moisture and skin conditioning in the period following treatment.

Problems solved by technology

However, its use in non-malignant conditions is limited, partly by worries about the risk of radiation-induced cancers.
It may also present with desquamation or blistering.
Skin reactions tend to be worse in areas where there are natural folds in the skin, such as underneath the female breast, behind the ear and in the groin.
Radiodermatitis can be painful and embarrassing and has been associated with decreased quality of life (Fisher et al 2000).
Severe radiodermatitis necessitates treatment modifications or delays, which may compromise the efficacy of radiotherapy (Hymes et al 2006).
However, an investigative survey by D'haese et al (2005) found that there is wide discrepancy between nursing interventions for the prevention and management of radiodermatitis.
These results suggest that there is confusion among oncology nurses (and likely their patients) regarding the prevention and management of radiodermatitis.
However, there is very little scientific support for any of these treatments.
However, this approach does not provide soothing or actively assist the healing of the damaged area.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0209]21 patients with advanced head and neck cancer undergoing radiochemotherapy and 8 patients with breast cancer undergoing radiotherapy applied the hydrogel and lotion during their course of treatment. The hydrogel was applied once a day within 2 hours of radiation and the lotion was applied four times a day. Clinical response was assessed during and shortly after radiotherapy. Physicians documented their findings on a standardised questionnaire.

TABLE 1patient characteristicsNo. patients withNo. side effects patientsfromdevelopingNo. Treat-hydrogel / radiation CancerpatientsProphylaxismentlotiondermatitisHead / neck2117403breast84400

example 2

[0210]The hydrogel and lotion were used by 26 patients. Application was uniform: At the beginning of the first symptoms of dermatitis (Erythema), the hydrogel was always applied on the affected area immediately after the radiotherapy, left there for about 20 minutes and then wiped off. The lotion was applied on the same area after 2-4 hours. The following applications of the lotion were individual and their frequency depended on the subjective feelings of each patient.

[0211]Of the total number of 26 patients, 15 patients were treated in the head and neck area, 8 patients in the thorax area during radiotherapy of breast cancer, and 3 patients in the pelvic area. Average duration of treatment was 4 weeks. For a majority of cases, the lotion was applied 2-3 times a day.

[0212]Twenty-five of 26 patients (96%) reported subjective feelings of relief, reduction of pain, burning or itching.

example 3

[0213]Between November 2010 and January 2011 ten patients with locally advanced head and neck cancer undergoing curative radiotherapy applied the hydrogel and lotion to the irradiated skin during the treatment period. The hydrogel was applied short time after radiation once a day, whereas the lotion was applied four to six times daily. The topical formulations were used during the whole radiation treatment period. Patients were examined, and toxicity was monitored weekly by an experience head and neck oncologist.

[0214]Two elderly patients could not manage to follow the instructions and only used the treatments regularly for 2-3 weeks of the treatment period.

[0215]The formulations were well tolerated and seemed to be an effective prophylaxis of acute radiation dermatitis. None of the patients developed grade III or IV dermatitis.

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Abstract

The present disclosure relates to topical formulations comprising purified water, milk protein fluid and thickener, in particular a hydrogel and a lotion, and their use in treatment of radiation dermatitis, in particular in a two-step process for the treatment of radiation dermatitis.

Description

[0001]The present invention relates to topical formulations comprising purified water, milk protein fluid and thickener, in particular a hydrogel and a lotion, and their use in treatment, in particular in a two-step process for the treatment of radiation dermatitis.BACKGROUND[0002]A radiation burn is damage to the skin or other biological tissue caused by exposure to radiation. The radiation types of greatest concern are thermal radiation, radio frequency energy, ultraviolet light and ionising radiation.[0003]Radiation therapy or radiotherapy is the medical use of ionising radiation, generally as part of cancer treatment to control or kill malignant cells. Radiation therapy may be curative in a number of types of cancer if the cancer cells are localised to one area of the body. It may also be used as part of curative therapy, to prevent tumour recurrence after surgery to remove a primary malignant tumour (for example, early stages of breast cancer). Radiation therapy is synergistic ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K35/20A61K38/01A61K31/12A61K31/133A61K31/216A61K31/275A61K9/00A61K47/10A61K47/14A61K47/18A61K9/06A61K31/047A61K47/46A61K47/36A61K47/32
CPCA61K35/20A61K38/018A61K9/0009A61K9/0014A61K47/10A61K47/14A61K47/18A61K9/06A61K47/46A61K47/36A61K47/32A61K31/047A61K31/133A61K31/275A61K31/12A61K31/216A61P17/00A61K2300/00
Inventor LAIT, MARKBISHOP, GEORGE
Owner SAFEGUARD MEDICAL HOLDCO LLC
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