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

Running, not enrolling · Phase 3

Conditions studied: Breast Carcinoma, Mastectomy Patient

In brief

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 facts

Study ID

NCT04989504

Run by

Alliance for Clinical Trials in Oncology

People needed

216

Starts

2022-07-26

Expected to finish

2029-02-15

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Aspirus Cancer Care - Wisconsin Rapids — Wisconsin Rapids, Wisconsin, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Gene Upshaw Memorial Tahoe Forest Cancer Center — Truckee, California, United States
• Beebe South Coastal Health Campus — Frankford, Delaware, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
• Beebe Health Campus — Rehoboth Beach, Delaware, United States
• John Fitzgerald Kennedy Medical Center — Atlantis, Florida, United States
• McFarland Clinic - Ames — Ames, Iowa, United States
• Mercy Hospital — Cedar Rapids, Iowa, United States
• Oncology Associates at Mercy Medical Center — Cedar Rapids, Iowa, United States
• Mercy Cancer Center-West Lakes — Clive, Iowa, United States
• Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates-Des Moines — Des Moines, Iowa, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• MaineHealth Coastal Cancer Treatment Center — Bath, Maine, United States
• Maine Medical Center-Bramhall Campus — Portland, Maine, United States
• MaineHealth Cancer Care Center of York County — Sanford, Maine, United States
• Maine Medical Center- Scarborough Campus — Scarborough, Maine, United States
• Anne Arundel Medical Center — Annapolis, Maryland, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Central Maryland Radiation Oncology in Howard County — Columbia, Maryland, United States
• UM Baltimore Washington Medical Center/Tate Cancer Center — Glen Burnie, Maryland, United States
• UM Saint Joseph Medical Center — Towson, Maryland, United States

Full record on ClinicalTrials.gov

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