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

NCT04989504 | Active Not Recruiting Phase 3 Results DMC FDA Device

• 3 other identifiers: A221803NCI-2019-04688UG1CA189823
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 49

Brief 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.

Conditions

Breast Carcinoma; Mastectomy Patient

Outcome Measures

Primary Outcomes (1)

• Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores

  Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a patient-completed mRISRAS score ranges from 0 to 12, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.

  Up to 5 months

Secondary Outcomes (3)

• Centralized, Blinded Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores Obtained From a Blinded Grading of the Photographs Taken at the End of Radiation Therapy

  Up to 2 months

• Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores

  Up to 5 months

• Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores

  Up to 5 months

Study Arms (2)

Arm I (standard of care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (Mepitel Film)

EXPERIMENTAL

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

Device: Wound Dressing Material; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: Standard of Care

Arm I (standard of care)

Wound Dressing Material DEVICE

Apply Mepitel Film

Arm II (Mepitel Film)

Quality-of-Life Assessment OTHER

Ancillary studies

Arm I (standard of care); Arm II (Mepitel Film)

Questionnaire Administration OTHER

Ancillary studies

Arm I (standard of care); Arm II (Mepitel Film)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (49)

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Beebe South Coastal Health Campus

Frankford, Delaware, 19945, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

John Fitzgerald Kennedy Medical Center

Atlantis, Florida, 33462, United States

Location

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

Location

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

Location

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, 04530, United States

Location

Maine Medical Center-Bramhall Campus

Portland, Maine, 04102, United States

Location

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073, United States

Location

Maine Medical Center- Scarborough Campus

Scarborough, Maine, 04074, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044, United States

Location

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061, United States

Location

UM Saint Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Saint Joseph Mercy Brighton

Brighton, Michigan, 48114, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Dickstein Cancer Treatment Center

White Plains, New York, 10601, United States

Location

Altru Cancer Center

Grand Forks, North Dakota, 58201, United States

Location

Holy Redeemer Hospital and Medical Center

Meadowbrook, Pennsylvania, 19046, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Tidelands Georgetown Memorial Hospital

Georgetown, South Carolina, 29440, United States

Location

Saint Francis Hospital

Greenville, South Carolina, 29601, United States

Location

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

Location

MUSC Health Tidelands Health Radiation Therapy Center

Murrells Inlet, South Carolina, 29576, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Doctor's Hospital of Laredo

Laredo, Texas, 78041, United States

Location

University of Utah Sugarhouse Health Center

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

Location

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Bandages

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Equipment and Supplies

Results Point of Contact

• Title: Dr. Kimberly Corbin
• Organization: Mayo Clinic

corbin.kimberly@mayo.edu

855-776-0015

Study Officials

• Kimberly Corbin, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: July 26, 2022
• Primary Completion: May 29, 2024
• Study Completion (Estimated): February 15, 2029
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (49)