Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel

Study Overview
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Brief Summary
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The radiotherapy after surgery reduces the risk of recurrence and death is widely used for standard treatment for cancer including breast cancer and head and neck cancer. However, radiation dermatitis is a common side effect and major adverse event of radiotherapy. Radiation induces skin inflammation resulting in redness, itchiness and peeling skin. Radiation dermatitis may be acute or chronic. Acute skin changes occur within 90 days of initiating therapy due to inflammation and DNA damage and chronic skin changes may occur after several weeks or years. Radiation-irritated skin is a treatment-induced symptom caused by radiation dose-limiting toxicity. It damages skin structure and causes a variety of symptoms of cuticle thinning, reducing of collagen in subcutaneous, sweat glands damage, sebaceous glands damage and basal membrane damage. These conditions lead patients to lost work productivity, wound care costs, social isolation, altered body image and affect a patient's quality of life and mental health both during and after treatment and even interrupts the treatment schedule. The treatment of radiation dermatitis is an essential component of radiotherapy. The common treatment includes agents and other dressing products, such as corticosteroid cream, hyaluronic acid, aloe and sucralfate, which are used to prevent or reduce severity of dermatitis. But there is no clear therapeutic or nursing guideline supporting continuous treatment of radiation dermatitis by topical agents currently. In this study, Radiation Care® gel which contain Japanese honeysuckle extract will be used in breast and head and neck cancer patients to test the safety and efficacy to prevent radiation dermatitis and alleviate their radiation-irritated skin symptoms. The primary objective of this study is to evaluate the clinical outcomes of Radiation Care gel application in breast cancer and head and neck cancer patients who have radiation dermatitis or radiation-irritated skin due to the radiotherapy.

Official Title
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A Single Center, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Other: Radiation Care Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be males or non-pregnant or non-lactating females at least 20 years of age. Subject must meet one of the following conditions: Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment. Diagnosis of epithelial carcinoma of nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, paranasal sinus and salivary glands which were treated with or without operation, concurrent chemotherapy is accepted, in head and neck cancer patients. Patients were scheduled to receive at least three sessions of radiotherapy per week (1 session per day) for at least five weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 50 Gy. Participant willing and must give signed informed consent. Exclusion Criteria: Prior breast reconstructions, implants, and/or expanders. Previous radiotherapy to the area to be treated with radiation therapy (head and neck area or breast and thorax areas). Concurrent chemotherapy in breast cancer patients. Concurrent targeted therapy in head and neck cancer patients. Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia) Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections, rashes or unhealed wounds in the radiation field or systemic lupus erythematosus (SLE). Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure. Use of a tissue-equivalent bolus. Use of over-the-counter topical medications containing steroids. Participation in any clinical trial in the prior 30 days from baseline. Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation Care Gel application<br>Radiation Care® gel is instructed to use on the target skin area accepted radiation therapy twice daily. | Other: Radiation Care Gel<br>* The investigational medical product of this study is a hydrogel, Radiation Care® gel which increases moisturizing and it can be applied to the target areas including skin folds and creases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe the proportion of patients with grade 2 radiation dermatitis (according to CTCAE) at week 5. | According to Common Terminology Criteria for Adverse Events (CTCAE) system by national cancer institute, radiation induced skin toxicities is scored in severity in the following grades: Grade 1: faint erythema or dry desquamation Grade 2: moderate to brisk erythema; moist desquamation confined to skin folds; moderate edema Grade 3: moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: skin necrosis or large ulcerations; spontaneous bleeding or require surgical procedures Grade 5: with lethal consequences | at 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate radiation-irritated situation after 3 months of Radiation Care® gel application in breast cancer and head and neck cancer patients who completed the post-operative radiotherapy. | The skin condition of target area will be observed and recorded at clinical visit. The measurement include: Erythema grade: Grade 1: Very faint erythema: Skin has a very light pink color. Grade 2: Faint erythema: Skin reaction is more apparent with clear borders but is still pink with more intensity. Grade 3: Bright erythema: Erythema is apparent in bright pink and borders are clearly defined. Grade 4: Very bright erythema: Skin is bright red, borders are very well defined, capillaries and bruising may be visible. Graded according to CTCAE rate Moisture percentage will be detected by MoistureMeter SC | Day0 (baseline), 1-Week, 2-Week, 3-Week, 4-Week, 5-Week, 6-Week, 7-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week | 
| To compare the moisture percentage at the radiotherapy site from baseline to follow-up visit. | Moisture percentage will be detected by MoistureMeter SC for every two weeks. | Up to 12-13 weeks (depend on different times of radiotherapy in breast cancer and head and neck cancer): From Day0 (baseline) to 2-Week, 4-Week, 6-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week (End of study) | 
| The score of quality of life with the Skindex-16 questionnaire performed every two weeks. | The Skindex-16 is an assessment using numerical analog scales (0 = never bothered to 6 = always bothered), used to comprehensively measure the effects of skin diseases on subject's quality of life including burden of symptoms, social function and emotional state that the CTCAE does not take into account. The higher scores present poorer quality of life. | Up to 12-13 weeks (depend on different times of radiotherapy in breast cancer and head and neck cancer): From Day0 (baseline) to 2-Week, 4-Week, 6-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week (End of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lonicera japonica, breast cancer, head and neck cancer