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

NCT04300829 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2021-02-04

No results posted yet for this study

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)

Conditions

  • Breast Adenocarcinoma
  • Radiation Dermatitis
  • Radiation Toxicity

Interventions

DRUG

cicaderma + simple hygiene rules

Cicaderma ointment (2 applications / day: after the radiotherapy session) and in the evening) + simple hygiene rules

OTHER

Simple hygiene rules and a maximum of one topical treatment

Simple hygiene rules according to the site recommandations including eventually a maximum of one topical treatment

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Séverine RACADOT, MD · Centre Leon Berard

  • Youlia KIROVA, MD PhD · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-06
Primary Completion
2022-09-09
Completion
2022-10-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04300829 on ClinicalTrials.gov