[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506446":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":209,"collaborators":211,"id":215,"slug":24,"hasResults":216,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":216,"sex":222,"minAge":223,"maxAge":24,"enrollmentInfo":224,"targetDuration":24,"studyType":227,"phases":228,"briefSummary":230,"conditions":231,"keywords":235,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},{"fullName":5,"class":6},"Association Francaise pour la Recherche Thermale","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate spa treatment","ACTIVE_COMPARATOR","The spa treatment must be carried out within a maximum of 6 weeks after 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Sellami","s.sellami@nancy.unicancer.fr",{"facility":28,"status":197,"city":198,"state":24,"zip":199,"country":200,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"NOT_YET_RECRUITING","Esch-sur-Alzette","L-4240","Luxembourg",{"type":48,"coordinates":202},[203,204],5.98056,49.49583,{"lat":204,"lon":203},[207],{"name":27,"role":33,"phone":24,"phoneExt":24,"email":208},"guillaume.vogin@baclesse.lu",{"type":210,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[212],{"name":213,"class":214},"Floralis","INDUSTRY","100506446",false,"NCT05874492","Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer","Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer in Remission","FIBROTHERME","Inclusion Criteria:\n\n* Age ≥ 18 years\n* In situ or invasive breast cancer or cancer of the upper aerodigestive tract\n* DLQI ≥ 6 (at least moderate effect on patient's life)\n* General status WHO 0-1\n* Radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay)\n* Unilateral breast radiotherapy for breast cancer patients\n* Skin or soft tissue toxicity (- modules: Skin atrophy, fibrosis of deep connective tissues, fibrosis of superficial soft tissues) CTCAE v4.0 grade ≥ 2\n* No inflammatory or infectious flare at inclusion\n* Female of childbearing potential: negative urine pregnancy test at inclusion\n* Patient informed and signed consent\n* Affiliation to a social security systeme or equivalent\n\nExclusion Criteria:\n\n* Progressive phase of cancer\n* Metastatic disease\n* Patient undergoing specific treatment for breast cancer (except adjuvant hormone therapy and\u002For adjuvant herceptin)\n* Bilateral breast\u002Fparietal radiotherapy\n* Breast prosthesis wearer for breast cancer patients\n* Patient with a tracheostomy for patients with head and neck cancer\n* Obvious skin ulceration in the site of interest\n* Contraindication to spa treatment (acute inflammatory disease, active infections, heart failure with NYHA stage \\> 1, chronic respiratory failure, labile hypertension, bullous disease)\n* Chronic progressive dermatological disease\n* Women who are pregnant or likely to become pregnant within 6 months or who are breastfeeding\n* Persons deprived of liberty or under guardianship","ALL","18 Years",{"count":225,"type":226},110,"ESTIMATED","INTERVENTIONAL",[229],"NA","FIBROTHERME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial.\n\nThe 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\u002For soft tissues at least 6 months after radiotherapy for breast cancer or UADT (Upper Aerodigestive Tract) cancer.",[232,233,234],"Fibrosis","Breast Cancer","Head and Neck Cancer",[236,237,238,239,240],"fibrosis","breast cancer","radiotherapy","spa treatment","head and neck cancer","2026-04-08",{"date":243,"type":244},"2026-04-13","ACTUAL",{"date":246,"type":244},"2024-01-29",{"date":248,"type":226},"2027-12",{"name":5,"class":6},13]