Actively Recruiting
Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer
Led by Association Francaise pour la Recherche Thermale · Updated on 2026-04-13
110
Participants Needed
13
Research Sites
200 weeks
Total Duration
On this page
Sponsors
A
Association Francaise pour la Recherche Thermale
Lead Sponsor
F
Floralis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with in situ or invasive breast cancer or upper aerodigestive tract cancer
- Dermatology Life Quality Index (DLQI) score of 6 or higher
- General health status WHO 0-1
- Completed radiotherapy at least 6 months ago
- Unilateral breast radiotherapy for breast cancer patients
- Skin or soft tissue toxicity grade 2 or higher by CTCAE v4.0
- No active inflammatory or infectious flare at enrollment
- Negative urine pregnancy test for females of childbearing potential
- Informed consent signed
- Affiliated with a social security system or equivalent
You will not qualify if you...
- Cancer in a progressive phase
- Metastatic disease
- Receiving specific breast cancer treatments except adjuvant hormone therapy or herceptin
- Bilateral breast or chest wall radiotherapy
- Wearing breast prosthesis (for breast cancer patients)
- Having a tracheostomy (for head and neck cancer patients)
- Obvious skin ulceration at the treatment site
- Contraindications to spa therapy such as acute inflammatory disease, active infections, heart failure NYHA stage > 1, chronic respiratory failure, labile hypertension, bullous disease
- Chronic progressive dermatological diseases
- Pregnant, breastfeeding, or likely to become pregnant within 6 months
- Persons deprived of liberty or under guardianship
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Clinique Tivoli-Ducos
Bordeaux, France, 33000
Actively Recruiting
2
Centre Hospitalier Intercommunal Créteil
Créteil, France, 94000
Actively Recruiting
3
Institut de Cancérologie de Bourgogne
Dijon, France, 21000
Actively Recruiting
4
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, France, 38000
Actively Recruiting
5
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France, 38000
Actively Recruiting
6
Institut Rafael
Levallois-Perret, France
Actively Recruiting
7
Institut Paoli-Calmettes
Marseille, France, 13009
Actively Recruiting
8
Centre Azuréen de Cancérologie
Mougins, France
Actively Recruiting
9
Centre Eugène Marquis
Rennes, France, 35000
Actively Recruiting
10
Centre Hospitalier Roanne
Roanne, France
Actively Recruiting
11
CHU Saint Etienne
Saint-Etienne, France
Actively Recruiting
12
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
13
Centre François Baclesse
Esch-sur-Alzette, Luxembourg, L-4240
Not Yet Recruiting
Research Team
N
Nans FUSTIER
CONTACT
C
Claire Eychenne
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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