NCT05874492Recruiting
Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer
Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer in Remission
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 13 Apr 2023
- Start date
- 29 Jan 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Diseases
- Head and neck cancer
- NCT number
- NCT05874492
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 29 Jan 2024 to the primary completion date, Dec 2026
- 13 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Bilateral breast/parietal radiotherapy
Other illness
- Progressive phase of cancer
- Metastatic disease
- Patient undergoing specific treatment for breast cancer (except adjuvant hormone therapy and/or adjuvant herceptin)
- Breast prosthesis wearer for breast cancer patients
- Patient with a tracheostomy for patients with head and neck cancer
- 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
Other
- Obvious skin ulceration in the site of interest
- Women who are pregnant or likely to become pregnant within 6 months or who are breastfeeding
- Persons deprived of liberty or under guardianship
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Tivoli-Ducos Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Institut de Cancérologie de Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre hospitalier universitaire Grenoble-Alpes Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Groupe Hospitalier Mutualiste de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Institut Rafael Coordinator of this site? Confirm its status | Levallois-Perret | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Azuréen de Cancérologie Coordinator of this site? Confirm its status | Mougins | France | Recruiting |
| Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Hospitalier Roanne Coordinator of this site? Confirm its status | Roanne | France | Recruiting |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
| Institut de Cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
| Centre François Baclesse Coordinator of this site? Confirm its status | Esch-sur-Alzette | Luxembourg | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.