Finding studies
Finding studies
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Lead
Alliance for Clinical Trials in Oncology
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
