This phase III trial studies how well Mepitel Film works in reducing radiation dermatitis (redness and peeling) in patients with breast cancer during radiation therapy after a mastectomy. Mepitel Film may reduce the severity of skin redness and peeling in the area of radiation.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Histologic confirmation of breast malignancy with TNM staging.
- Patients must have undergone a mastectomy with or without reconstruction within the past 120 days if not receiving adjuvant therapy, or within 60 days after completion of the last dose of chemotherapy.
- No prior radiotherapy to any portion of the planned treatment site.
- No documented history of adhesive or tape allergy.
- Patients must be scheduled to receive conventionally fractionated photon-based radiation. Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation or hypofractionated radiation are not eligible.
- No active rash or pre-existing dermatitis within the treatment field.
- No co-existing medical conditions resulting in life expectancy < 2 years.
- No active collagen vascular diseases (i.e. lupus erythematosus, scleroderma, dermatomyositis).
- No concomitant cytotoxic chemotherapy. Endocrine therapy and HER2 directed therapies are allowed.
- No current inflammatory breast cancer, or gross dermal involvement at initiation of radiotherapy.
- No previous history of organ or bone marrow transplant.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- In order to complete the mandatory patient-completed measures, participants must be able to speak and read English.
Alliance for Clinical Trials in Oncology