[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Association Francaise pour la Recherche Thermale\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100506446","evaluation-of-the-medical-benefit-of-spa-therapy-on-fibrosis-after-radiotherapy-for-breast-cancer-or-uadt-upper-aerodigestive-tract-cancer-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":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Fibrosis","Breast Cancer","Head and Neck Cancer",[31,32,33,34,35],"fibrosis","breast cancer","radiotherapy","spa treatment","head and neck cancer","RECRUITING","2026-04-08",{"date":39,"type":40},"2026-04-13","ACTUAL",{"date":42,"type":40},"2024-01-29",{"date":44,"type":21},"2027-12",{"name":46,"class":47},"Association Francaise pour la Recherche Thermale","OTHER",13,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100595218","thermal-spa-treatment-and-improvement-of-primary-ciliary-dyskinesia-100595218","NCT07029594","Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia","Interest of Thermal Spa Treatment in Improving ENT-Related Quality of Life in Patients With Primary Ciliary Dyskinesia","CANDY","Inclusion Criteria:\n\n* Confirmed diagnosis of Primary Ciliary Dyskinesia (PCD) based on electron microscopy analysis of ciliary ultrastructure and\u002For genetic testing (i.e., two unambiguous mutations in genes known to be involved in PCD, particularly in cases with normal ciliary ultrastructure \\[\\~20% of patients\\], atypical ultrastructural findings, or suggestive symptoms in a family with a known causal gene).\n* Age over 18 years.\n* Stable maintenance treatment for at least 1 month prior to inclusion.\n* Performance Status (PS) ≤ 1.\n* Patient has received the study information sheet and signed the informed consent form.\n* Patient has valid health insurance coverage.\n\nExclusion Criteria:\n\n* Participation in a thermal spa treatment within the past year.\n* Severe general health deterioration or debilitating conditions.\n* Severe or recent heart failure.\n* Labile hypertension.\n* Venous insufficiency or deep vein thrombosis within the past 3 months.\n* Recent unhealed fracture.\n* Unhealed skin lesions (wounds, pressure sores, eczema).\n* Contagious or progressive diseases.\n* Recent cancer (less than 5 years).\n* Ongoing or recent (within the past month) pulmonary or ENT exacerbation at inclusion.\n* Ongoing treatment with immunomodulatory or immunosuppressive drugs (due to the risk of potentially severe opportunistic infections).\n* Ongoing or recent (within the past month) extra-respiratory or ENT infectious flare-up.\n* Positive pre-cure bacteriological testing for multidrug-resistant Pseudomonas aeruginosa, MRSA, Mycobacterium abscessus, or other multidrug-resistant pathogenic bacteria.\n* Fever \\> 38.5°C.\n* Recently worsened dyspnea (\\\u003C 1 month).\n* History of serious adverse effects or intolerance during a previous thermal spa treatment.\n* Participation in another clinical trial with an exclusion period.\n* Considered a vulnerable person, as defined by Articles L1121-5 to L1121-8 of the French Public Health Code:\n\nPregnant women, women in labor, and breastfeeding mothers.\n\nIndividuals deprived of liberty by judicial or administrative decision, or those hospitalized without consent under Articles L.3212-1 and L.3213-1 (excluding Article L.1121-8), and persons admitted to a healthcare or social institution for reasons other than research.\n\nAdults under legal protection or unable to give informed consent.",{"count":58,"type":21},35,[24],"The goal of this clinical trial is to evaluate whether a 3-week thermal spa treatment can improve quality of life and reduce ENT (ear, nose, and throat) symptoms in adults with Primary Ciliary Dyskinesia (PCD). PCD is a rare, chronic condition that affects the airways and often leads to persistent sinus, ear, and lung infections.\n\nThe main questions the study aims to answer are:\n\nDoes spa therapy improve ENT-related symptoms and daily quality of life?\n\nDoes it help reduce the frequency of infections and the need for antibiotics?\n\nAre there improvements in hearing and lung function?\n\nIn this study, participants will be randomly assigned to one of two groups:\n\nGroup A will begin with a 3-week spa treatment, followed by regular checkups for 6 months.\n\nGroup B will start with standard care for 6 months, then receive the spa treatment and follow-up evaluations for another 6 months.\n\nAll participants will:\n\nUndergo ENT and lung function evaluations (questionnaires, hearing tests, nasal swabs, spirometry)\n\nVisit one of two spa centers for a 3-week treatment period (without hospital stay)\n\nBe followed regularly over several months for checkups and tests\n\nResearchers will compare participants' symptoms and test results before and after the spa treatment to determine its benefits.\n\nPotential benefits:\n\nParticipants may experience relief from nasal symptoms, fewer respiratory infections, improved hearing and breathing, and an overall better quality of life.\n\nPotential risks:\n\nThere is a small risk of infection from a new germ or a mild, short-term flare-up of chronic symptoms (called a \"thermal reaction\") that can occur during spa therapy.",[62],"Primary Ciliary Dyskinesia","2025-06-12",{"date":65,"type":40},"2025-06-19",{"date":67,"type":21},"2025-09-05",{"date":69,"type":21},"2027-05-05",{"name":46,"class":47},1,""]