Informations générales (source: ClinicalTrials.gov)
Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission (FIBROTHERME)
Interventional
N/A
Association Francaise pour la Recherche Thermale (Voir sur ClinicalTrials)
janvier 2024
avril 2026
05 avril 2025
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 the end of postoperative radiotherapy for breast cancer.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Azuréen de Cancérologie - Mougins - France | Alexander FALK | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - 35000 - Rennes - France | Mohamed Benchalal | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Roanne - Roanne - France | Amel BLANCHARD | Contact (sur clinicalTrials) | |||
| CHU Saint Etienne - Saint Etienne - France | Aurélie BENETON | Contact (sur clinicalTrials) | |||
| Clinique Tivoli-Ducos - 33000 - Bordeaux - France | Christophe Debelleix | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Mutualiste de Grenoble - 38000 - Grenoble - France | Marie-Virginie Claeys | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Bourgogne - 21000 - Dijon - France | Benjamin Schipman | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - 54519 - Vandœuvre-lès-Nancy - France | Selima Sellami | Contact (sur clinicalTrials) | |||
| Institut Rafael - Levallois Perret - France | Alain TOLEDANO | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Female
- Age ≥ 18 years
- In situ or invasive breast cancer
- DLQI ≥ 6 (at least moderate effect on patient's life)
- General status WHO 0-1
- Post-operative radiotherapy completed at least 6 months ago (with no maximum post
radiotherapy delay)
- Unilateral breast radiotherapy
- Skin or soft tissue toxicity (- modules: Skin and subcutaneous tissue disorders /
Musculoskeletal disorders / Reproductive organs and breast disorders) CTCAE v4.0
grade ≥ 2
- No inflammatory or infectious flare at inclusion
- Female of childbearing potential: negative urine pregnancy test at inclusion
- Patient informed and signed consent
- Affiliation to a social security systeme or equivalent
- Female
- Age ≥ 18 years
- In situ or invasive breast cancer
- DLQI ≥ 6 (at least moderate effect on patient's life)
- General status WHO 0-1
- Post-operative radiotherapy completed at least 6 months ago (with no maximum post
radiotherapy delay)
- Unilateral breast radiotherapy
- Skin or soft tissue toxicity (- modules: Skin and subcutaneous tissue disorders /
Musculoskeletal disorders / Reproductive organs and breast disorders) CTCAE v4.0
grade ≥ 2
- No inflammatory or infectious flare at inclusion
- Female of childbearing potential: negative urine pregnancy test at inclusion
- Patient informed and signed consent
- Affiliation to a social security systeme or equivalent
- 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
- Breast prosthesis wearer
- Obvious skin ulceration in the treated breast
- Contraindication to spa treatment (acute inflammatory disease, active infections,
heart failure with NYHA stage > 1, chronic respiratory failure, labile hypertension,
bullous disease)
- Chronic progressive dermatological disease
- Women who are pregnant or likely to become pregnant within 6 months or who are
breastfeeding
- Persons deprived of liberty or under guardianship