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

PRIMARY OBJECTIVE:

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.

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 provider assessment.

IV. To evaluate time to local and/or regional failure.

V. To determine the frequency and severity of acute adverse events.

VI. To determine the frequency and severity of chronic radiation therapy-related adverse events including skin and soft tissue fibrosis, telangiectasia, and hyperpigmentation.

EXPLORATORY OBJECTIVES:

I. To determine the ability of Mepitel Film to decrease the rate of reconstruction complications.

II. To determine the ability of Mepitel Film to decrease the rate of reconstruction failure.

III. To determine the number of Mepitel Film changes required during treatment, evaluate ease of use from a nursing perspective, and estimate financial cost of the intervention.

IV. To determine the frequency and severity of patient-reported itching, radiation skin reaction, pain, and breast swelling and tenderness.

V. To determine the long-term severity of radiation dermatitis, as measured by the combined patient- and provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores obtained at 6-months, 1-year, and 2-years post-radiation therapy.

VI. To conduct psychometric testing of the mRISRAS.

CORRELATIVE SCIENCE OBJECTIVE:

I. To obtain skin swabs for future analysis of the impact of ionizing radiation and Mepitel Film on the skin microbiome and Staphylococcus aureus (Staph aureus) through 16S deep sequencing and targeted droplet digital polymerase chain reaction and/or quantitative polymerase chain reaction (PCR), respectively.

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 as needed or once every 2 weeks 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, 2 years, then every 6 months up to 5 years.