Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT04989504
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.
Study:
NCT04989504
Study Brief:
Protocol Section:
NCT04989504