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

Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Carcinoma; Mastectomy Patient
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Best Practice; Device: Wound Dressing Material

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kimberly Corbin, MD; Phone Number: 855-776-001; Email: corbin.kimberly@mayo.edu

Study Locations

• United States
  • California
    • Marysville, California, United States, 95901
      • Fremont - Rideout Cancer Center
    • Truckee, California, United States, 96161
      • Gene Upshaw Memorial Tahoe Forest Cancer Center
  • Delaware
    • Frankford, Delaware, United States, 19945
      • Beebe South Coastal Health Campus
    • Newark, Delaware, United States, 19713
      • Helen F Graham Cancer Center
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants PA
    • Rehoboth Beach, Delaware, United States, 19971
      • Beebe Health Campus
  • Florida
    • Atlantis, Florida, United States, 33462
      • John Fitzgerald Kennedy Medical Center
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic - Ames
    • Cedar Rapids, Iowa, United States, 52403
      • Mercy Hospital
    • Cedar Rapids, Iowa, United States, 52403
      • Oncology Associates at Mercy Medical Center
    • Clive, Iowa, United States, 50325
      • Mercy Cancer Center-West Lakes
    • Des Moines, Iowa, United States, 50309
      • Iowa Methodist Medical Center
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center - Des Moines
    • Des Moines, Iowa, United States, 50309
      • Medical Oncology and Hematology Associates-Des Moines
  • Maine
    • Bath, Maine, United States, 04530
      • MaineHealth Coastal Cancer Treatment Center
    • Portland, Maine, United States, 04102
      • Maine Medical Center-Bramhall Campus
    • Sanford, Maine, United States, 04073
      • MaineHealth Cancer Care Center of York County
    • Scarborough, Maine, United States, 04074
      • Maine Medical Center- Scarborough Campus
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
    • Baltimore, Maryland, United States, 21201
      • University of Maryland/Greenebaum Cancer Center
    • Columbia, Maryland, United States, 21044
      • Central Maryland Radiation Oncology in Howard County
    • Glen Burnie, Maryland, United States, 21061
      • UM Baltimore Washington Medical Center/Tate Cancer Center
    • Towson, Maryland, United States, 21204
      • UM Saint Joseph Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Saint Joseph Mercy Hospital
    • Brighton, Michigan, United States, 48114
      • Saint Joseph Mercy Brighton
    • Livonia, Michigan, United States, 48154
      • Trinity Health Saint Mary Mercy Livonia Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • Missouri
    • Rolla, Missouri, United States, 65401
      • Delbert Day Cancer Institute at PCRMC
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital Saint Louis
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic Cancer Center
  • New York
    • Glens Falls, New York, United States, 12801
      • Glens Falls Hospital
    • White Plains, New York, United States, 10601
      • Dickstein Cancer Treatment Center
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Altru Cancer Center
  • Pennsylvania
    • Meadowbrook, Pennsylvania, United States, 19046
      • Holy Redeemer Hospital and Medical Center
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health Cancer Center
    • Georgetown, South Carolina, United States, 29440
      • Tidelands Georgetown Memorial Hospital
    • Greenville, South Carolina, United States, 29607
      • Saint Francis Cancer Center
    • Greenville, South Carolina, United States, 29601
      • Saint Francis Hospital
    • Greer, South Carolina, United States, 29651
      • Gibbs Cancer Center-Pelham
    • Murrells Inlet, South Carolina, United States, 29576
      • MUSC Health Tidelands Health Radiation Therapy Center
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
  • Texas
    • Laredo, Texas, United States, 78041
      • Doctor's Hospital of Laredo
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute/University of Utah
    • Salt Lake City, Utah, United States, 84106
      • University of Utah Sugarhouse Health Center
  • Wisconsin
    • Appleton, Wisconsin, United States, 54911
      • ThedaCare Regional Cancer Center
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Regional Cancer Center
    • Wisconsin Rapids, Wisconsin, United States, 54494
      • Aspirus Cancer Care - Wisconsin Rapids

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (standard of care); Patients receive standard of care skin management during radiation therapy for up to 6 weeks.	Other: Quality-of-Life Assessment; Ancillary studies; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: Standard of Care
Experimental: Arm II (Mepitel Film); Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.	Other: Quality-of-Life Assessment; Ancillary studies; Other: Questionnaire Administration; Ancillary studies; Device: Wound Dressing Material; Apply Mepitel Film

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the completion of radiation therapy, photographs will be obtained one hour after the removal of the Mepitel Film or immediately following completion of radiation therapy for patients on the standard of care arm. A panel of radiation oncology providers will perform the blinded, central review to score the photographs. Each provider will independently assign a provider-completed mRISRAS score to each photograph, and the average score will be calculated for each patient. The provider-completed mRISRAS score ranges from 0 to 24, where higher scores correspond to increased radiation-induced skin reactions. The Wilcoxon rank-sum test will be used to test for an effect of the Mepitel Film.	Up to 2 months
Serially measured non-blinded institutional provider-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 provider-completed mRISRAS score ranges from 0 to 24, 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
Serially measured combined patient- and provider-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 provider-completed mRISRAS score ranges from 0 to 36, 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

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Kimberly Corbin, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: A221803; UG1CA189823 (U.S. NIH Grant/Contract); NCI-2019-04688 (Registry Identifier: NCI Clinical Trial Reporting Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes