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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04989504
• Other study ID #: A221803
• Secondary ID: NCI-2019-04688UG
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 26, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Other:
• Best Practice
Receive standard of care

Device:
• Wound Dressing Material
Apply Mepitel Film

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	McFarland Clinic - Ames	Ames	Iowa
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	ThedaCare Regional Cancer Center	Appleton	Wisconsin
United States	John Fitzgerald Kennedy Medical Center	Atlantis	Florida
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland
United States	MaineHealth Coastal Cancer Treatment Center	Bath	Maine
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Saint Joseph Mercy Brighton	Brighton	Michigan
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	Central Maryland Radiation Oncology in Howard County	Columbia	Maryland
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	Beebe South Coastal Health Campus	Frankford	Delaware
United States	Tidelands Georgetown Memorial Hospital	Georgetown	South Carolina
United States	UM Baltimore Washington Medical Center/Tate Cancer Center	Glen Burnie	Maryland
United States	Glens Falls Hospital	Glens Falls	New York
United States	Altru Cancer Center	Grand Forks	North Dakota
United States	Saint Francis Cancer Center	Greenville	South Carolina
United States	Saint Francis Hospital	Greenville	South Carolina
United States	Gibbs Cancer Center-Pelham	Greer	South Carolina
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	Trinity Health Saint Mary Mercy Livonia Hospital	Livonia	Michigan
United States	Fremont - Rideout Cancer Center	Marysville	California
United States	Holy Redeemer Hospital and Medical Center	Meadowbrook	Pennsylvania
United States	MUSC Health Tidelands Health Radiation Therapy Center	Murrells Inlet	South Carolina
United States	Helen F Graham Cancer Center	Newark	Delaware
United States	Medical Oncology Hematology Consultants PA	Newark	Delaware
United States	Maine Medical Center-Bramhall Campus	Portland	Maine
United States	Beebe Health Campus	Rehoboth Beach	Delaware
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah
United States	University of Utah Sugarhouse Health Center	Salt Lake City	Utah
United States	MaineHealth Cancer Care Center of York County	Sanford	Maine
United States	Maine Medical Center- Scarborough Campus	Scarborough	Maine
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	UM Saint Joseph Medical Center	Towson	Maryland
United States	Gene Upshaw Memorial Tahoe Forest Cancer Center	Truckee	California
United States	Aspirus Regional Cancer Center	Wausau	Wisconsin
United States	Dickstein Cancer Treatment Center	White Plains	New York
United States	Aspirus Cancer Care - Wisconsin Rapids	Wisconsin Rapids	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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