Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Jul 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special product called Mepitel Film to see if it can help reduce skin problems, like redness and peeling, during radiation therapy for breast cancer patients who have had a mastectomy (surgery to remove the breast). The goal is to find out if this film can make the skin feel better and look healthier while patients are receiving radiation treatment.

To participate in the trial, patients should be between 65 and 74 years old and must have recently had a mastectomy. They should not have had any previous radiation in the same area or have certain skin conditions or allergies. Additionally, participants need to be scheduled for specific types of radiation therapy. If they join the trial, patients can expect to use the Mepitel Film during their radiation sessions and complete some questionnaires about their experience. This trial is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.