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 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.