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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

RecruitingNAAges 18 Years - anyAllAssociation Francaise pour la Recherche Thermale
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Thermal cure with a primary dermatological indication
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Where

13 sites
Clinique Tivoli-Ducos
Bordeaux, France
Centre Hospitalier Intercommunal Créteil
Créteil, France
Institut de Cancérologie de Bourgogne
Dijon, France
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Institut Rafael
Levallois-Perret, France
Institut Paoli-Calmettes
Marseille, France
Centre Azuréen de Cancérologie
Mougins, France

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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