A Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy

Study Overview
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Brief Summary
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The breast radiotherapy after breast-conserving surgery reduces the risk of recurrence and death and is widely used for standard treatment for breast cancer. However, radiation dermatitis is a major adverse event of breast radiotherapy. 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, sweat glands damage, sebaceous glands damage and basal membrane damage. Radiation-irritated skin also leads to lost work productivity, wound care costs, social isolation and altered body image. Thus, radiation-irritated skin can greatly impact the quality of life. Several studies have examined the effects of numerous topical agents to reduce the dryness of skin. However, the reported results have not been clinically significant. Previous studies have shown that deer antler velvet extract possess inflammatory function and repair damaged follicles, sweat glands and sebaceous gland. And biocellulose membrane is a highly efficient media to introduce velvet extract to damaged skin tissue. In this study, velvet extract combined with biocellolose membrane will be used in breast cancer patients to test the safety and efficacy to alleviate their radiation-irritated skin symptoms. The investigational medical product of this study is a biomedical repair mask, FR-MASK ;the formula of FR-Mask is deer antler velvet, which is a traditional Chinese tonic medicine combined with high-adhesion biocellulose membrane. The primary objective of this study is to test the safety and clinical outcomes of FR-Mask application in breast cancer patients who have radiation-irritated skin due to the post-operative radiotherapy.

Official Title
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A Single-arm, Open Label, Single Center Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: FR-Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be males or non-pregnant females at least 20 years of age. Diagnosis of, non-inflammatory breast adenocarcinoma or in situ breast cancer and completed post-operative radiotherapy without concurrent chemotherapy. Breast adenocarcinoma previously treated by unilateral lumpectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment. 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 45 Gy. A time period of at least two weeks after radiotherapy before beginning the study. Participant must give informed consent. Exclusion Criteria: Bilateral breast cancer Previous radiotherapy to the chest Chemotherapy concurrent with radiation treatment Prior breast reconstructions, implants, and/or expanders Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia) Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE) 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: FR-Mask application<br> | Other: FR-Mask<br>* The investigational medical product of this study is a biomedical repair mask, FR-MASK, acting like moisturizing lotion applied on breasts. The FR-Mask is applied to users' radiation-irritated breast skin for 15 to 20 minutes every 3 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of scores of study questionnaire between baseline and each time point used to evaluate the breast cosmetic domain and specific breast pain domain. | Breast Cancer Treatment Outcome: Scale 1 = no difference between treated and untreated breast and area; 2 = slight difference between treated and untreated breast and area; 3 = moderate difference between treated and untreated breast and area; 4 = large difference between treated and untreated breast and area | Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of moisture(water) percentage between baseline and each time point measured by skin analyzer (skin observed system) and skin checker (by electrical conductivity). |  | Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month | 
| The change of oil percentage between baseline and each time point measured by skin analyzer (skin observed system) and skin checker (by electrical conductivity). |  | Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month | 
| The change of pigment percentage between baseline and each time point measured by skin analyzer (skin observed system). |  | Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month | 
| The change of sensitivity percentage between baseline and each time point measured by skin analyzer (skin observed system). |  | Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deer antler velvet, radiation-irritated skin