[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653401":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":44,"interventions":56,"overallOfficials":63,"centralContacts":70,"locations":80,"responsibleParty":169,"collaborators":37,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":37,"eligibilityCriteria":178,"healthyVolunteers":174,"sex":179,"minAge":180,"maxAge":37,"enrollmentInfo":181,"targetDuration":37,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":193,"overallStatus":196,"whyStopped":37,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"West Virginia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of at least one Grade ≥3 Treatment-Related Toxicities of Interest","Incidence of participants experiencing at least one Grade ≥3 according to National Cancer Institute Common Terminology Criteria for Adverse Events v6.0 (NCI CTCAE) treatment-related toxicity of interest, including mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, or trismus, during concurrent chemoradiotherapy.","From initiation of concurrent chemoradiotherapy through completion of treatment (approximately 6-7 weeks)",[14,17,21,25,29,32,35],{"measure":15,"description":16,"timeFrame":12},"Incidences of Individual Treatment-Related Toxicities of Interest","Incidence of treatment-related mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus of any grade, as assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.",{"measure":18,"description":19,"timeFrame":20},"Incidence of Enteric Tube Placement","Incidence of participants requiring enteric feeding tube placement during treatment and follow-up.","From initiation of treatment through 6 months after completion of chemoradiotherapy",{"measure":22,"description":23,"timeFrame":24},"Incidence of Hematologic Toxicities","Incidence of leukopenia, anemia, and thrombocytopenia assessed during weeks 3-6 of concurrent chemoradiotherapy treatment as assessed according to NCI CTCAE v6.0.","Weeks 3-6 of concurrent chemoradiotherapy",{"measure":26,"description":27,"timeFrame":28},"Residual Grade of Toxicities of Interest at 3 Months","Residual severity (NCI CTCAE v6.0 Grades 0-5) of mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.","3 months after completion of chemoradiotherapy",{"measure":30,"description":27,"timeFrame":31},"Residual grade of Toxicities of Interest at 6 Months","6 months after completion of chemoradiotherapy",{"measure":33,"description":34,"timeFrame":28},"Complete Recovery of Toxicities of Interest at 3 Months","Incidence of participants with complete recovery (NCI CTCAE v6.0 Grade 0) from mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus.",{"measure":36,"description":34,"timeFrame":31},"Complete Recovery of Toxicities of Interest at 6 Months",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Scheduled IV Hydration","EXPERIMENTAL","Participants will receive scheduled IV hydration approximately twice per week throughout the treatment period. IV fluids will continue even if chemoradiotherapy infusion is held due to toxicities or cytopenias.",[50],"Other: Scheduled IV Hydration",{"label":52,"type":6,"description":53,"interventionNames":54},"Clinician Assessment-Based IV Hydration","Participants will receive IV fluids (normal saline) only as clinically indicated and ordered by their treating clinician, per standard of care. IV fluids may continue if chemoradiotherapy infusion is held due to toxicities or cytopenias, at the discretion of the treating clinician.",[55],"Other: Clinician Assessment-Based IV Hydration",[57,60],{"type":6,"name":46,"description":58,"armGroupLabels":59,"otherNames":37},"Normal saline (0.9% sodium chloride) 1L of saline will be administered at each hydration visit. Participants will receive IV fluids on a planned schedule of twice a week, starting in Week 3 of chemoradiation treatment and continuing for one week after treatment is completed.",[46],{"type":6,"name":52,"description":61,"armGroupLabels":62,"otherNames":37},"IV fluids (normal saline (0.9% sodium chloride)) only as clinically indicated and ordered by their treating clinician, per standard of care.",[52],[64,68],{"name":65,"affiliation":66,"role":67},"Sidra Najeeb, MD","WVU Cancer Center","PRINCIPAL_INVESTIGATOR",{"name":69,"affiliation":66,"role":67},"David Clump, MD, PhD",[71,76],{"name":72,"role":73,"phone":74,"phoneExt":37,"email":75},"Nina Moore","CONTACT","304-293-2991","nina.moore@hsc.wvu.edu",{"name":77,"role":73,"phone":78,"phoneExt":37,"email":79},"Ella Betler","304-293-4273","eibetler@hsc.wvu.edu",[81,99,113,127,141,155],{"facility":82,"status":37,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"WVU Medicine United Hospital Center","Bridgeport","West Virginia","26330","United States","US",{"type":89,"coordinates":90},"Point",[91,92],-80.2562,39.28648,{"lat":92,"lon":91},[95],{"name":96,"role":73,"phone":97,"phoneExt":37,"email":98},"Sabrina Rexroad","681-342-1000","sabrina.rexroad1@wvumedicine.org",{"facility":100,"status":37,"city":101,"state":84,"zip":102,"country":86,"countryCode":87,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"WVU Medicine Berkeley Medical Center","Martinsburg","25401",{"type":89,"coordinates":104},[105,106],-77.96389,39.45621,{"lat":106,"lon":105},[109],{"name":110,"role":73,"phone":111,"phoneExt":37,"email":112},"Valli White","304-264-1220","valli.white@wvumedicine.org",{"facility":114,"status":37,"city":115,"state":84,"zip":116,"country":86,"countryCode":87,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"West Virginia University Cancer Institute","Morgantown","26506",{"type":89,"coordinates":118},[119,120],-79.9559,39.62953,{"lat":120,"lon":119},[123,124,125,126],{"name":72,"role":73,"phone":74,"phoneExt":37,"email":75},{"name":77,"role":73,"phone":78,"phoneExt":37,"email":79},{"name":65,"role":67,"phone":37,"phoneExt":37,"email":37},{"name":69,"role":67,"phone":37,"phoneExt":37,"email":37},{"facility":128,"status":37,"city":129,"state":84,"zip":130,"country":86,"countryCode":87,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"WVU Medicine Camden Clark Medical Center","Parkersburg","26101",{"type":89,"coordinates":132},[133,134],-81.56151,39.26674,{"lat":134,"lon":133},[137],{"name":138,"role":73,"phone":139,"phoneExt":37,"email":140},"Layla Tannaoury","304-424-2585","Layla.tannoury@wvumedicine.org,",{"facility":142,"status":37,"city":143,"state":84,"zip":144,"country":86,"countryCode":87,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"WVU Medicine Princeton Community Hospital","Princeton","24740",{"type":89,"coordinates":146},[147,148],-81.10259,37.36623,{"lat":148,"lon":147},[151],{"name":152,"role":73,"phone":153,"phoneExt":37,"email":154},"Melissa Boggess","304-487-7515","melissa.boggess1@wvumedicine.org",{"facility":156,"status":37,"city":157,"state":84,"zip":158,"country":86,"countryCode":87,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"WVU Medicine Wheeling Hospital","Wheeling","26003",{"type":89,"coordinates":160},[161,162],-80.72091,40.06396,{"lat":162,"lon":161},[165],{"name":166,"role":73,"phone":167,"phoneExt":37,"email":168},"Maher Kali","304-243-7045","maher.kali@wvumedicine.org",{"type":67,"investigatorFullName":170,"investigatorTitle":171,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"David Clump","Professor and Chair Department of Radiology WVU Cancer Center","100653401","scheduled-iv-fluids-in-the-supportive-management-of-patients-undergoing-chemo-radiotherapy-for-head-and-neck-cancer-100653401",false,"NCT07784855","Scheduled IV Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer","WVU011625: The Role of Scheduled Intravenous Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer","Inclusion Criteria:\n\n* ECOG 0-2\n* Non-nasopharyngeal squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx primary\n* Planned for concurrent chemoradiotherapy (CCRT) with standard-of-care cisplatin-based regimen (IV cisplatin 100mg\u002Fm2 once every three weeks for up to three doses or IV cisplatin 40mg\u002Fm2 weekly) with concurrent radiotherapy (treatment duration approximately 6-7 weeks, per institutional standards).\n* The use of immunotherapy in combination with CCRT is permitted and does not affect eligibility or group assignment.\n\nExclusion Criteria:\n\n* Nasopharyngeal squamous cell carcinomas, nasal cavity and paranasal sinus squamous cell carcinomas.\n* History of congestive heart failure.\n* Dependency on enteral nutrition and hydration prior to enrollment.\n* Use of diuretics that cannot be safely held during study treatment (participants who are able to temporarily discontinue diuretics during treatment are eligible).","ALL","18 Years",{"count":182,"type":183},180,"ESTIMATED","INTERVENTIONAL",[186],"NA","Patients undergoing concurrent chemoradiotherapy (CCRT) for head and neck squamous cell carcinoma frequently experience treatment-related toxicities including mucositis, dysphagia, acute kidney injury, pain, constipation, dermatitis, xerostomia, and trismus. Many of these toxicities may be exacerbated by dehydration and are commonly managed with clinician-directed intravenous (IV) hydration. This study will evaluate whether scheduled IV hydration reduces the incidence and severity of treatment-related toxicities compared with clinician assessment-based hydration. Participants will be randomized 1:1 to scheduled IV hydration or clinician assessment-based IV hydration beginning in Week 3 of concurrent chemoradiotherapy and continuing through one week following completion of chemoradiotherapy.",[189,190,191,192],"Squamous Cell Carcinoma of Hypopharynx","Squamous Cell Carcinoma of Larynx","Squamous Cell Carcinoma of Oropharynx","Squamous Cell Carcinoma of Oral Cavity",[194,195],"Treatment related toxicities","IV hydration","NOT_YET_RECRUITING","2026-08-21",{"date":199,"type":200},"2026-08-25","ACTUAL",{"date":202,"type":183},"2026-10",{"date":204,"type":183},"2029-04",{"name":5,"class":6},6]