Clinical trial · Interventional
Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients
Randomised Multicentric Phase III Study Evaluating the Efficacy of Cicaderma vs Standard Management of Each Site in Preventing Radiodermatitis After Adjuvant Post-operative Breast Irradiation in Patients With Non-metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Adenocarcinoma | Breast Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Radiation Dermatitis | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cicaderma + simple hygiene rules | Drug | — | UNRESOLVED |
| Simple hygiene rules and a maximum of one topical treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Simple hygiene rules of the site + Cicaderma ointment
- description
- Hygiene rules (use of a neutral soap, no bath, use of non-alcoholic products, delicate drying of the skin, wearing of cotton clothing) and Cicaderma ointment application)
- interventionNames
- Drug: cicaderma + simple hygiene rules
- type
- ACTIVE_COMPARATOR
- label
- Preventive standard cares
- description
- Preventive standard cares of the site including hygiene rules (use of a neutral soap, no bath, use of non-alcoholic products, delicate drying of the skin, wearing of cotton clothing) and a maximum of one topical treatment
- interventionNames
- Other: Simple hygiene rules and a maximum of one topical treatment
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRacadot S, Arnaud A, Schiffler C, Metzger S, Perol D, Kirova Y. Cicaderma(R) in radiation-related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT. Clin Transl Radiat Oncol. 2023 Jun 1;41:100647. doi: 10.1016/j.ctro.2023.100647. eCollection 2023 Jul. PMID 37441546