Radiation Toxicity Clinical Trial
— CICA-RTOfficial title:
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
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)
Status | Recruiting |
Enrollment | 248 |
Est. completion date | October 9, 2022 |
Est. primary completion date | September 9, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Institut Sainte-Catherine | Avignon | |
France | Institut Curie | Paris | |
France | Institut Curie | Saint-Cloud |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the Cicaderma ointment efficacy versus the standard management of each site in preventing the onset of grade >= 2 radiodermatitis (NCI-CTCAE-V5) | Number of patients presenting >= 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5) | Up to 30+/-4 days after the end of radiotherapy interruption | |
Secondary | Patients' satisfaction | Patients' satisfaction evaluated using the "Patient's evaluation of the preventive management of radiodermatits" - Likert scale in 5 points (from very unsatisfied to very satisfied) | 30+/-4 days after the end of radiotherapy interruption | |
Secondary | Patients' quality of life: DLQI questionnaire | Patients' quality of life evaluated using the Dermatology Life Quality Index (DLQI) questionnaire (validated questionnaire composed of 10 items leading to a global score) | Up to 30+/-4 days after the end of radiotherapy interruption | |
Secondary | Patients' pain in the irradiated area: numeric scale | Patients' pain evaluated using a numeric scale from 0 (no pain) to 10 (unbearable pain) | Up to 30+/-4 days after the end of radiotherapy interruption | |
Secondary | Rate of temporary or permanent RT interruption related to the onset of grade 3 radiodermatitis | Temporary or permanent radiotherapy interruption related to the onset of grade 3 radiodermatitis observed during patients' treatment period | Through radiotherapy completion, an average of 5 weeks | |
Secondary | Rate of prurit onset whatever the grade | Prurit onset whatever the grade observed | Up to 30+/-4 days after the end of radiotherapy interruption | |
Secondary | Doses of radiation therapy received | Doses of radiation therapy received during each radiotherapy session | Through radiotherapy completion, an average of 5 weeks | |
Secondary | Delay of onset of the first cutaneous event (radiodermatitis or prurit) grade =2 | Onset of the first grade >= 2 cutaneous event (radiodermatitis or prurit) | Up to 30+/-4 days after the end of radiotherapy | |
Secondary | Compliance with the Cicaderma ointment application (experimental arm) | Compliance evaluated according to the ointment tubes brought back by the patients (not used or partially used) and patient's diary | Up to 30+/-4 days after the end of radiotherapy | |
Secondary | Determination of the factors measured prior to treatment initiation which are associated to the onset of grade =2 radiodermatitis (cup size) | Cup size | At inclusion | |
Secondary | Determination of the factors measured prior to treatment initiation which are associated to the onset of grade =2 radiodermatitis (phototype) | Phototype | At inclusion |
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