Cicaderma® in radiation-related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT.

ABSTRACT:

Background and purpose

To prevent the occurrence of grade ≥ 2 radiodermatitis after post-operative breast irradiation in patients with non metastatic breast cancer.

Methods

This prospective randomised open-label multicenter study allocated patients from 3 French institutions, ≥18 years, requiring postoperative radiotherapy for histologically proven, early-stage (non-metastatic) unilateral breast adenocarcinoma or in situ breast cancer, with R0 or R1 post-operative status, to receive hygiene rules, associated with either Cicaderma® (Arm A), or preventive treatment according to the investigator preference (mainly hyaluronic acid (ialuset®), essential oils, or water spray, or no medication (Arm B). The primary outcome was to compare the efficacy of Cicaderma® versus loca

SUBMITTER: Racadot S 

PROVIDER: S-EPMC10334129 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature