Status:
UNKNOWN
Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients
Lead Sponsor:
Centre Leon Berard
Conditions:
Breast Adenocarcinoma
Radiation Dermatitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 pre...
Detailed Description
Breast cancer is the most common cancer in women. It accounts for more than 1/3 of new cancer cases and is the 1st cause of death for women. Management usually includes tumorectomy or mastectomy prec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 9 2022
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04300829
Start Date
June 6 2020
End Date
October 9 2022
Last Update
February 4 2021
Active Locations (3)
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1
Institut Sainte-Catherine
Avignon, France, 84000
2
Institut Curie
Paris, France, 75005
3
Institut Curie
Saint-Cloud, France, 92210