Skin and Connective Tissue Diseases

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Radiodermatitis

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Skin Diseases

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

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

Best Practice

Wound Dressing Material

Quality-of-Life Assessment

Questionnaire Administration

Kimberly Corbin, MD

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.

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.

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

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy	NCT04989504	Breast Carcinom... Mastectomy Pati...	Best Practice Wound Dressing ... Quality-of-Life... Questionnaire A...	18 Years -	Alliance for Clinical Trials in Oncology
Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy	NCT04989504	Breast Carcinom... Mastectomy Pati...	Best Practice Wound Dressing ... Quality-of-Life... Questionnaire A...	18 Years -	Alliance for Clinical Trials in Oncology
Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy	NCT04989504	Breast Carcinom... Mastectomy Pati...	Best Practice Wound Dressing ... Quality-of-Life... Questionnaire A...	18 Years -	Alliance for Clinical Trials in Oncology
Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy	NCT04989504	Breast Carcinom... Mastectomy Pati...	Best Practice Wound Dressing ... Quality-of-Life... Questionnaire A...	18 Years -	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for mastectomy patient