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

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 (R) (Arm A), or preventive treatment according to the investigator preference (mainly hyaluronic acid (ialuset (R)), essential oils, or water spray, or no medication (Arm B). The primary outcome was to compare the efficacy of Cicaderma (R) versus local standard management in preventing the occurrence of grade >= 2 radiodermatitis. Main secondary objectives include Cicaderma (R) impact on radiotherapy discontinuation and on skin toxicity (pruritus), pain, quality of life, satisfaction. Results: The CICA-RT study enrolled from June 2020 to April 2021, 258 women with a median age of 61 (22-91) years in 3 institutions. Patients received either Cicaderma (R) (A: N = 130) or standard practice (B: N = 128). In the 123 patients who initiated radiotherapy in each arm, 95 (77%, 95%CI 68.8%-84.3%) patients did not develop grade >= 2 dermatitis. Sensitivity and per-protocol analyses confirmed the absence of differences between arms. Conclusion: This prospective study did not meet its primary endpoint of superiority of Cicaderma (R) over routine practice skin care in terms of prevention of acute radioinduced dermatitis of grade 2 or higher. However, Cicaderma (R) showed a significant decrease in the occurrence of pruritus with less patients reporting at least once grade >= 2 pruritus (A: N = 38, 31%; B: N = 58, 47%; p = 0.009). ClinicalTrials.gov identifier NCT04300829.