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

Phase 3

Active, not recruiting

Conditions: Breast Carcinoma
Mastectomy Patient

Registration Number: NCT04989504

Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 216

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores	Up to 5 months	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores	Up to 5 months	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.
Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores	Up to 5 months	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.

Trial Locations

Locations (49): 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
Scroll for more (39 remaining)
Fremont - Rideout Cancer Center
🇺🇸Marysville, California, United States