Breast adenocarcinoma treated with post-operative radiotherapy Post-operative breast cancer radiotherapy
Conditions
Interventions
Trade Name: Cicaderma®
Pharmaceutical Form: Ointment
Sponsors
Centre Léon Bérard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Age=18 years I2. Patient requiring a post-operative radiotherapy (post mastectomy or tumorectomy) for a one-sided early stage (non-metastatic) histologically documented mammary adenocarcinoma or in-situ breast cancer I3. No residual tumor (R0 or R1) I4. Signed informed consent prior to any study-specific procedure I5. Covered by a medical insurance Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 148 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: E1. Unsolved cutaneous event caused by any previous treatment E2. Hormonotherapy started before the radiation therapy E3. Patients using concomitant topical treatment on the irradiated area excluding those prescribed for the study E4. Patient concurrently using chemotherapy and/or targeted therapy E5. Known hypersensibility to one or more ingredients of Cicaderma® or of another topical treatment E6. Patient for whom the follow-up seems to be impossible (even a short-term follow-up) E7 Pregnant or breastfeeding woman E8 Participation to another clinical trial which may interfere with principal endpoint assessment E9 Patient requiring tutorship or curatorship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of Cicaderma® ointment versus the standard care of each center in the prevention of grade > 2 radiation dermatitis according to National Cancer Institute – Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5);Secondary Objective: • To evaluate in each arm: • Patients’ satisfaction • Patients’ quality of life • Patients’ pain for the irradiated area • The rate of temporary or definitive radiotherapy interruptions due to grade 3 radiation dermatitis onset • The rate of pruritus onset whatever the grade • The radiotherapy doses received • The onset delay of the first grade =2 cutaneous event (radiodermatitis or pruritus) • To evaluate in the experimental arm: • Compliance of Cicaderma application • To determine the factors associated to the grade =2 radiation dermatitis onset ;Primary end point(s): Success rate defined as patient not experiencing any grade =2 radiation dermatitis within the 30 +/- 4 days after the end of radiotherapy;Timepoint(s) of evaluation of this end point: 30 +/- 4 days after the end of radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Patients’ satisfaction (Likert scale), • Quality of life (DLQI Questionnaire), • Patients’ pain for the irradiated area (Numeric scale from 0 [no pain] to 10 [imaginable maximal pain), • The rate of temporary of definitive radiotherapy interruptions due to grade 3 radiation dermatitis onset, • The rate of pruritus onset whatever the grade, • The radiotherapy doses received, • Delay of grade =2 cutaneous toxicity onset (radiation dermatitis / pruritus), • Compliance of Cicaderma application (experimental arm), • Determination of assessed factors at inclusion potentially associated with grade =2 radiation dermatitis onset. ;Timepoint(s) of evaluation of this end point: • Likert scale at 30 +/- 4 days after the end of radiotherapy, • DLQI questionnaire at inclusion, at each weekly visit during radiotherapy and at 30 +/- 4 days after the end of radiotherapy, • Numerical scale at inclusion, at each weekly visit during radiotherapy and at 30 +/- 4 days after the end of radiotherapy, • Rate of temporary of definitive Cicaderma interruptions due to grade 3 radiation, dermatitis at each weekly visit during the radiotherapy, • Pruritus onset evaluated at each weekly visit during radiotherapy and at 30+/- 4 days after the end of radiotherapy, • Compliance to Cicaderma® application using patient’s diary, • Radiotherapy doses received at each session, • ... | — |
Countries
France
Contacts
Public ContactSéverine
Centre Léon Bérard
Outcome results
None listed