[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100277527":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":11,"locations":26,"responsibleParty":191,"collaborators":11,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":195,"sex":200,"minAge":201,"maxAge":11,"enrollmentInfo":202,"targetDuration":11,"studyType":205,"phases":206,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":221,"whyStopped":222,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"fullName":5,"class":6},"Rennes University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early active swallowing therapy","EXPERIMENTAL",null,[13],"Other: Swallowing therapy",{"label":15,"type":16,"description":11,"interventionNames":11},"Usual care","NO_INTERVENTION",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"Swallowing therapy","Patients will undergo active swallowing therapy with a speech and language therapist (twice a week) combined to a detailed program of swallowing auto-exercises (twice a day) from start of radiotherapy to one month after the end.",[9],[23],{"name":24,"affiliation":5,"role":25},"Franck JEGOUX","PRINCIPAL_INVESTIGATOR",[27,38,46,51,59,67,75,83,91,99,107,115,123,131,139,147,151,159,167,175,183],{"facility":28,"status":11,"city":29,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":11},"Brest University 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Hospital","Tours",{"type":33,"coordinates":171},[172,173],0.70398,47.39484,{"lat":173,"lon":172},{"facility":176,"status":11,"city":177,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":178,"geoPoint":182,"contacts":11},"Bretagne Atlantique Hospital","Vannes",{"type":33,"coordinates":179},[180,181],-2.76205,47.65688,{"lat":181,"lon":180},{"facility":184,"status":11,"city":185,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":186,"geoPoint":190,"contacts":11},"Institut Gustave Roussy","Villejuif",{"type":33,"coordinates":187},[188,189],2.35992,48.7939,{"lat":189,"lon":188},{"type":192,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100277527","evaluation-of-an-active-swallowing-rehabilitation-on-quality-of-life-of-patients-treated-by-radiotherapy-for-head-and-neck-cancer-100277527",false,"NCT02892487","Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer","RORC","Inclusion Criteria:\n\n* Patient treated for histologically proven head and neck cancer (oral cavity, oropharynx, or hypopharynx cancer) of stages I-IV or larynx cancer of stages II-IV, all histologic type, without distant metastasis\n* Indication of curative radiotherapy alone or associated to chemotherapy or targeted therapy, without planned surgery\n* WHO (World Health Organization) Performance Status 0, 1 or 2\n* Sufficient cognitive capacities to complete a QoL questionnaire (evaluation by the physician at inclusion)\n* Written informed consent\n* Patients with health insurance\n\nExclusion Criteria:\n\n* Previous radiotherapy or surgery of the upper aerodigestive tract\n* Cancer of paranasal sinuses or nasopharynx or skull base\n* Medical history of nervous system disease associated to significant sequelae in terms of dysphagia\n* Pregnant or breast-feeding woman\n* Patient under guardianship, trusteeship or judicial protection","ALL","18 Years",{"count":203,"type":204},183,"ACTUAL","INTERVENTIONAL",[207],"NA","Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program.\n\nThe main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.\n\nThe study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).",[210],"Cancer of Head and Neck",[212,213,214,215,216,217,218,219,220],"Quality of life","Radiotherapy","Dysphagia","Oral cavity","Oropharynx","Hypopharynx","Larynx","Swallowing rehabilitation","Toxicity","TERMINATED","For financial reasons and speed of recruitment was much slower than expected, inclusions weren't resumed after it was suspended during COVID-19 confinment.","2023-11-15",{"date":225,"type":204},"2023-11-18",{"date":227,"type":204},"2016-12-09",{"date":229,"type":204},"2021-06",{"name":5,"class":6},21]