About this trial
FIBROTHERME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial.
The aim of this study is to evaluate the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis 6 months after a dermatologically oriented spa therapy in patients with severe late reactions affecting the skin and/or soft tissues at least 6 months after radiotherapy for breast cancer or UADT (Upper Aerodigestive Tract) cancer.
Eligibility criteria
Qualifiers
Age ≥ 18 years
In situ or invasive breast cancer or cancer of the upper aerodigestive tract
DLQI ≥ 6 (at least moderate effect on patient's life)
General status WHO 0-1
Disqualifiers
Progressive phase of cancer
Metastatic disease
Patient undergoing specific treatment for breast cancer (except adjuvant hormone therapy and/or adjuvant herceptin)
Bilateral breast/parietal radiotherapy
Trial design
Treatments tested in this trial
- Thermal cure with a primary dermatological indication
Treatment groups
Sponsors and collaborators
Association Francaise pour la Recherche Thermale
Lead sponsor
Floralis
Collaborator