Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
Breast Cancer, Radiation Dermatitis
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring radiation-irritated skin
Eligibility Criteria
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 which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment. Patients were scheduled to receive five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy or hypofraction irradiation fraction(with 2.66 Gy per session) for total dose of at least 42.56 Gy. 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.
Sites / Locations
Arms of the Study
Arm 1
Experimental
FR-101 Dressing use
Subject will use FR-101 chest dressing on the target skin area accepted radiation therapy once every 2 days.