Status:
RECRUITING
Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer
Lead Sponsor:
Association Francaise pour la Recherche Thermale
Collaborating Sponsors:
Floralis
Conditions:
Fibrosis
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Radiation-induced fibrosis is an equivalent of an "orphan disease", in which oncologists have only recently shown interest, despite its prevalence. No study on the medical service provided by crenothe...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05874492
Start Date
January 29 2024
End Date
December 1 2027
Last Update
April 13 2026
Active Locations (13)
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1
Clinique Tivoli-Ducos
Bordeaux, France, 33000
2
Centre Hospitalier Intercommunal Créteil
Créteil, France, 94000
3
Institut de Cancérologie de Bourgogne
Dijon, France, 21000
4
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, France, 38000