[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602623":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"National Cancer Center, Korea","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Blad-Care (sodium hyaluronate 1.6%, 800 mg\u002F50 mL, BioPlus Co., Ltd.)",[13],"Device: Blad-Care (sodium hyaluronate 1.6%, 800 mg\u002F50 mL, BioPlus Co., Ltd.)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","Normal saline (N.S.)",[19],"Other: Normal Saline (NS)",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Bladder instillation of Blad-Care (sodium hyaluronate 1.6%, 800 mg\u002F50 mL, BioPlus Co., Ltd.) will be administered aseptically once weekly for a total of five times following each session of radiotherapy.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"OTHER","Normal Saline (NS)","Normal saline will be instilled into the bladder following the same schedule as the intervention group, i.e., five times after each radiotherapy session.",[15],[32],{"name":33,"affiliation":34,"role":35},"Sung Uk Lee, MD, PhD","Center for Proton Therapy, National Cancer Center, Korea","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Eui Hyun Jung, PhD","CONTACT","821046593407","jeh0315@ncc.re.kr",[43],{"facility":5,"status":25,"city":44,"state":45,"zip":46,"country":47,"countryCode":25,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Goyang-si","Gyeonggi-do","10408","South Korea",{"type":49,"coordinates":50},"Point",[51,52],126.835,37.65639,{"lat":52,"lon":51},[55],{"name":38,"role":39,"phone":56,"phoneExt":25,"email":41},"82319202451",{"type":35,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Sung Uk Lee","M.D., Ph.D.","100602623","intravesical-hyaluronic-acid-ha-for-preventing-radiation-cystitis-on-bladder-cancer-100602623",false,"NCT07125924","Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer","Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer : A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Pathologic confirmed Muscle-Invasive Urothelial Carcinoma I. Clinical stage: T2-T4a MIBC II. No or limited nodal involvement (N0 or partial N1, only isolated or regional) III. No distant metastasis (M0) IV. Transurethral resection of bladder tumor (TURBT): Maximal TURBT is available \\> Most tumors must be resected, and residual disease should be minimized.\n\n   V. Preserved bladder function is required: patients must have normal bladder capacity and maintain adequate voiding function.\n\n   VI. Unifocal or localized tumor (except multifocal) VII. No extensive carcinoma in situ (CIS)\n2. Age ≥ 19\n3. Karnofsky performance score (KPS) ≥ 70 or ECOG performance status 0\\~2\n4. Patients who are candidates for bladder-preserving therapy, specifically those scheduled to undergo concurrent chemoradiotherapy (CCRT) instead of radical cystectomy.\n5. Patients scheduled to receive radiotherapy in combination with one or more of the following chemotherapeutic agents prior to study enrollment: Cisplatin-based chemotherapy (e.g. weekly cisplatin), Gemcitabine or 5-FU\u002Fmitomycin, in accordance with standard clinical practice.\n6. Written informed consent obtained from the patients prior to study participation\n\nExclusion Criteria:\n\n1. Present of distant metastasis (M1)\n2. Tumor invasion beyond the bladder wall into adjacent organs (T4b)\n3. Non-urothelial carcinoma (including histologic variant) or predominant of non-urothelial components in mixed histology\n4. Medically inoperable status or poor general condition (ECOG performance status \\> 2)\n5. History of active cystitis or recurrent urinary tract infections within the past 6 months\n6. Known hypersensitivity to hyaluronic acid or related compounds\n7. Any condition in which, in the investigator's judgment, administration of the study drug or procedure is deemed inappropriate\n8. Pregnant or breastfeeding women, or women of childbearing potential who are unable or unwilling to use adequate contraception during the study period",true,"ALL","19 Years",{"count":71,"type":72},54,"ESTIMATED","INTERVENTIONAL",[75],"NA","To evaluate the efficacy and safety of intravesical hyaluronic acid (HA) instillation therapy for the prevention of radiation-induced cystitis in patients undergoing radiotherapy for bladder cancer.",[78,79],"Bladder Cancer","Radiation Cystitis",[81,79,82,83],"Hyaluronic acid","Intravesical treatment","Prevention","NOT_YET_RECRUITING","2025-08-09",{"date":87,"type":88},"2025-08-15","ACTUAL",{"date":90,"type":72},"2025-08-22",{"date":92,"type":72},"2027-12-31",{"name":5,"class":6},1]