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

Last updated: January 15, 2025
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Active - Not Recruiting

Phase

3

Condition

Carcinoma

Cancer/tumors

Treatment

Quality-of-Life Assessment

Best Practice

Wound Dressing Material

Clinical Study ID

NCT04989504
A221803
UG1CA189823
NCI-2019-04688
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 216
Treatment Group(s): 4
Primary Treatment: Quality-of-Life Assessment
Phase: 3
Study Start date:
July 26, 2022
Estimated Completion Date:
February 15, 2029

Study Description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. To determine the ability of Mepitel Film to reduce the severity of radiation dermatitis in patients undergoing post-mastectomy radiotherapy for breast cancer when compared to the institutional standard of care.

KEY SECONDARY OBJECTIVES:

I. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a centralized, blinded provider assessment review of photographs.

II. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a non-blinded institutional provider assessment.

III. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a combined patient and non-blinded institutional provider assessment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care skin management during radiation therapy for up to 6 weeks.

ARM II: Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.

After completion of study, patients are followed up at 7-14 days, 3 months, 6 months, 1 year, and 2 years.

Connect with a study center

  • Fremont - Rideout Cancer Center

    Marysville, California 95901
    United States

    Site Not Available

  • Gene Upshaw Memorial Tahoe Forest Cancer Center

    Truckee, California 96161
    United States

    Site Not Available

  • Beebe South Coastal Health Campus

    Frankford, Delaware 19945
    United States

    Site Not Available

  • Helen F Graham Cancer Center

    Newark, Delaware 19713
    United States

    Site Not Available

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware 19713
    United States

    Site Not Available

  • Beebe Health Campus

    Rehoboth Beach, Delaware 19971
    United States

    Site Not Available

  • John Fitzgerald Kennedy Medical Center

    Atlantis, Florida 33462
    United States

    Site Not Available

  • McFarland Clinic - Ames

    Ames, Iowa 50010
    United States

    Site Not Available

  • McFarland Clinic PC - Ames

    Ames, Iowa 50010
    United States

    Active - Recruiting

  • Mercy Hospital

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • Mercy Cancer Center-West Lakes

    Clive, Iowa 50325
    United States

    Site Not Available

  • Iowa Methodist Medical Center

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine 04530
    United States

    Site Not Available

  • Maine Medical Center-Bramhall Campus

    Portland, Maine 04102
    United States

    Site Not Available

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine 04073
    United States

    Site Not Available

  • Maine Medical Center- Scarborough Campus

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Anne Arundel Medical Center

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland 21044
    United States

    Site Not Available

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland 21061
    United States

    Site Not Available

  • UM Saint Joseph Medical Center

    Towson, Maryland 21204
    United States

    Site Not Available

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Saint Joseph Mercy Brighton

    Brighton, Michigan 48114
    United States

    Site Not Available

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan 48154
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri 65401
    United States

    Site Not Available

  • Mercy Hospital Saint Louis

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Mercy Hospital Springfield

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Billings Clinic Cancer Center

    Billings, Montana 59101
    United States

    Site Not Available

  • Glens Falls Hospital

    Glens Falls, New York 12801
    United States

    Site Not Available

  • Dickstein Cancer Treatment Center

    White Plains, New York 10601
    United States

    Site Not Available

  • Altru Cancer Center

    Grand Forks, North Dakota 58201
    United States

    Site Not Available

  • Holy Redeemer Hospital and Medical Center

    Meadowbrook, Pennsylvania 19046
    United States

    Site Not Available

  • AnMed Health Cancer Center

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina 29440
    United States

    Site Not Available

  • Saint Francis Cancer Center

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Saint Francis Hospital

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina 29651
    United States

    Site Not Available

  • MUSC Health Tidelands Health Radiation Therapy Center

    Murrells Inlet, South Carolina 29576
    United States

    Site Not Available

  • Spartanburg Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Doctor's Hospital of Laredo

    Laredo, Texas 78041
    United States

    Site Not Available

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Utah Sugarhouse Health Center

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin 54911
    United States

    Site Not Available

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin 54401
    United States

    Site Not Available

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin 54494
    United States

    Site Not Available

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