[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451942":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":74,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":18,"enrollmentInfo":90,"targetDuration":18,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Jessa Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Patients allocated to the treatment group will receive institutional standard vaginal care in combined with twice weekly PBMT sessions during the radiotherapy course and until two weeks after the end of radiotherapy.",[13],"Device: Intimleds",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Patients allocated to the control group will receive institutional standard vaginal care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Intimleds","INTIMILEDS® is a photobiomodulation device designed for intravaginal use. It's design permits an irradiation of the whole vaginal wall, the vulva, and the cervix, with a constant intensity.",[9],[26],{"name":27,"affiliation":5,"role":28},"Jeroen Mebis, Prof. Dr.","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+32 11 33 72 21","jeroen.mebis@jessazh.be",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Marithé Claes, MSc","+32 11 33 72 39","marithe.claes@uhasselt.be",[39,59],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Ziekenhuis Oost-Limburg","RECRUITING","Genk","Limburg","3600","Belgium","BE",{"type":48,"coordinates":49},"Point",[50,51],5.50082,50.965,{"lat":51,"lon":50},[54,58],{"name":55,"role":31,"phone":56,"phoneExt":18,"email":57},"Evelyn Van de Werf, Dr.","+32 89 32 65 61","Evelyn.VandeWerf@zol.be",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},{"facility":5,"status":41,"city":60,"state":43,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Hasselt","3500",{"type":48,"coordinates":63},[64,65],5.33781,50.93106,{"lat":65,"lon":64},[68,69,71],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":70,"role":31,"phone":36,"phoneExt":18,"email":37},"Marithé Marithé, MSc",{"name":72,"role":73,"phone":18,"phoneExt":18,"email":18},"Philippe Bulens, Dr.","SUB_INVESTIGATOR",{"type":75,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[77,78],{"name":40,"class":6},{"name":79,"class":6},"Hasselt University","100451942","photobiomodulation-therapy-in-the-prevention-and-management-of-radiotherapy-induced-vaginal-toxicity-100451942",false,"NCT05165056","Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity","Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity: a Randomized Controlled Trial","GynLight","Inclusion Criteria:\n\n* Diagnosed with endometrial cancer\n* Scheduled for external beam radiotherapy (EBRT), intracavitary brachytherapy (BT), or a combination\n* Age ≥ 18 years\n* Able to comply to the study protocol\n* Able to sign written informed consent\n\nExclusion Criteria:\n\n* Metastatic disease\n* Pregnancy\n* Diagnosis of vaginal stenosis before radiotherapy (RT)\n* Previous pelvic tumor or pelvic RT\n* Interruption of RT for more than five sessions\n* Severe psychological disorder or dementia.\n* Inability to speak and understand Dutch\n* Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator\n* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator","FEMALE","18 Years",{"count":91,"type":92},62,"ESTIMATED","INTERVENTIONAL",[95],"NA","This study aims to investigate the effectiveness of photobiomodulation therapy (PBMT) in the prevention and management of radiotherapy-induced vaginal toxicity (RIVT). Therefore, we hypothesize that PBMT can reduce the severity of RIVT in gynecological cancer patients, increasing the patient's QoL and sexual functioning.",[98,99],"Radiotherapy Side Effect","Vaginal Abnormality",[101],"Photobiomodulation therapy","2023-09-28",{"date":104,"type":105},"2023-09-29","ACTUAL",{"date":107,"type":105},"2022-08-24",{"date":109,"type":92},"2030-01",{"name":5,"class":6},2]