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

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.

ClinicalTrials.gov IDNCT05874492

PhaseNA

Enrollment110

SponsorAssociation Francaise pour la Recherche Thermale

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Fibrosis, Breast Cancer, Head and Neck Cancer

About this study

Interventions

Other: 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...)

Primary outcomes

Evaluation of the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis after a dermatologically oriented spa treatment. (6 months)

Eligibility information

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

Study locations

Clinique Tivoli-Ducos, Bordeaux, 33000 France
Centre Hospitalier Intercommunal Créteil, Créteil, 94000 France
Institut de Cancérologie de Bourgogne, Dijon, 21000 France
Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, 38000 France
Groupe Hospitalier Mutualiste de Grenoble, Grenoble, 38000 France
Institut Rafael, Levallois-Perret, France
Institut Paoli-Calmettes, Marseille, 13009 France
Centre Azuréen de Cancérologie, Mougins, France
Centre Eugène Marquis, Rennes, 35000 France
Centre Hospitalier Roanne, Roanne, France

Showing 10 of 13 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.