Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssociation Francaise pour la Recherche Thermale

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

110 Participants
are divided into 2 treatment groups

Locations

13
France
Clinique Tivoli-Ducos33000, Bordeaux France
Centre Hospitalier Intercommunal Créteil94000, Créteil France
Institut de Cancérologie de Bourgogne21000, Dijon France
Centre Hospitalier Universitaire Grenoble Alpes38000, Grenoble France

Sponsors and collaborators

Association Francaise pour la Recherche Thermale

Lead sponsor

Floralis

Collaborator