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Scheduled IV Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
Sponsor: West Virginia University
Summary
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.
Official title: WVU011625: The Role of Scheduled Intravenous Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-10
Completion Date
2029-04
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
Scheduled IV Hydration
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.
Clinician Assessment-Based IV Hydration
IV fluids (normal saline (0.9% sodium chloride)) only as clinically indicated and ordered by their treating clinician, per standard of care.
Locations (6)
WVU Medicine United Hospital Center
Bridgeport, West Virginia, United States
WVU Medicine Berkeley Medical Center
Martinsburg, West Virginia, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
WVU Medicine Camden Clark Medical Center
Parkersburg, West Virginia, United States
WVU Medicine Princeton Community Hospital
Princeton, West Virginia, United States
WVU Medicine Wheeling Hospital
Wheeling, West Virginia, United States