Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients

• Status: Recruiting
• Trial end date: 2022-10-09
• Target enrollment: 0
• Participant gender: Female

Summary

Phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms, evaluating the efficacy of Cicaderma ointment vs standard management of each site in preventing the onset of grade > 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard

Criteria

Inclusion Criteria:

• Age ≥18 years

• Patient requiring a post-operative radiotherapy (post mastectomy or tumorectomy) for a mammary adenocarcinoma or an unilateral in situ breast cancer histologically documented, early stage of disease (non metastatic)

• Patient with no residual tumor (R0 or R1)

• Patient informed and having given her signed consent

• Patient affiliated to a social security regimen

Exclusion Criteria:

• Unsolved cutaneous toxicities of any previous treatment

• Hormonotherapy started prior to radiotherapy

• Concomitant use of other topical treatments than the study treatments on the irradiated area

• Patient treated by concomitant chemotherapy and/or targeted therapy

• Known hypersensibility to at least one component of the topicals used or Cicadema ointment

• Patient for whom follow-up does not seem possible even in the short term

• Pregnant or breastfeeding woman

• Participation in another clinical trial that may interfere with the evaluation of the primary endpoint

• Patient Under tutorship or curatorship or deprived of liberty