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Clinical Trials in France / NCT05874492
Recruiting Not applicable

Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer

NCT05874492 · tracked via the Priya Life Science France tracker
Sponsor
Association Francaise pour la Recherche Thermale
Phase
Not applicable
Started
2024-01-29
Last updated
2026-04-13

Condition(s) studied

FibrosisBreast CancerHead and Neck Cancer

Investigational drug(s) / intervention(s)

Thermal cure with a primary dermatological indication

Thermal cure with a primary dermatological indication: The thermal treatment combines baths which have a sedative, muscle-relaxing effect and encourage joint mobilisation, sprays which have a decongestant effect and, above all, thread-like showers which are carried out by jets of thermal water under high pressure for several minutes plus educational workshops (relaxation, sophrology, hygiene...)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Clinique Tivoli-Ducos Bordeaux France Recruiting
Centre Hospitalier Intercommunal Créteil Créteil France Recruiting
Institut de Cancérologie de Bourgogne Dijon France Recruiting
Centre Hospitalier Universitaire Grenoble Alpes Grenoble France Recruiting
Groupe Hospitalier Mutualiste de Grenoble Grenoble France Recruiting
Institut Rafael Levallois-Perret France Recruiting
Institut Paoli-Calmettes Marseille France Recruiting
Centre Azuréen de Cancérologie Mougins France Recruiting
Centre Eugène Marquis Rennes France Recruiting
Centre Hospitalier Roanne Roanne France Recruiting
CHU Saint Etienne Saint-Etienne France Recruiting
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France Recruiting
Centre François Baclesse Esch-sur-Alzette Luxembourg Not Yet Recruiting

More Association Francaise pour la Recherche Thermale trials in France

Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05874492 on ClinicalTrials.gov ↗ ← All trials in France