Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer
Recruiting now · Not applicable
Conditions studied: Fibrosis, Breast Cancer, Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT05874492
- Run by
- Association Francaise pour la Recherche Thermale
- People needed
- 110
- Starts
- 2024-01-29
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay)
- Unilateral breast radiotherapy for breast cancer patients
- Skin or soft tissue toxicity (- modules: Skin atrophy, fibrosis of deep connective tissues, fibrosis of superficial soft tissues) 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
You may not qualify if…
- 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 for breast cancer patients
- Patient with a tracheostomy for patients with head and neck cancer
- Obvious skin ulceration in the site of interest
- 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
Where it is running
- Clinique Tivoli-Ducos — Bordeaux, France (enrolling)
- Centre Hospitalier Intercommunal Créteil — Créteil, France (enrolling)
- Institut de Cancérologie de Bourgogne — Dijon, France (enrolling)
- Centre Hospitalier Universitaire Grenoble Alpes — Grenoble, France (enrolling)
- Groupe Hospitalier Mutualiste de Grenoble — Grenoble, France (enrolling)
- Institut Rafael — Levallois-Perret, France (enrolling)
- Institut Paoli-Calmettes — Marseille, France (enrolling)
- Centre Azuréen de Cancérologie — Mougins, France (enrolling)
- Centre Eugène Marquis — Rennes, France (enrolling)
- Centre Hospitalier Roanne — Roanne, France (enrolling)
- CHU Saint Etienne — Saint-Etienne, France (enrolling)
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (enrolling)
- Centre François Baclesse — Esch-sur-Alzette, Luxembourg
Full record on ClinicalTrials.gov
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