NCT05874492 Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer
| NCT ID | NCT05874492 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Association Francaise pour la Recherche Thermale |
| Condition | Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-01-29 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-01-29 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Guillaume Vogin
PRINCIPAL INVESTIGATOR
Centre François Baclesse
Frequently Asked Questions
Who can join the NCT05874492 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05874492 currently recruiting?
Yes, NCT05874492 is actively recruiting participants. Contact the research team at nans.fustier@univ-grenoble-alpes.fr for enrollment information.
Where is the NCT05874492 trial being conducted?
This trial is being conducted at Bordeaux, France, Créteil, France, Dijon, France, Grenoble, France and 9 additional locations.
Who is sponsoring the NCT05874492 clinical trial?
NCT05874492 is sponsored by Association Francaise pour la Recherche Thermale. The principal investigator is Guillaume Vogin at Centre François Baclesse. The trial plans to enroll 110 participants.