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NOT YET RECRUITING
NCT07784855
NA

Scheduled IV Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer

Sponsor: West Virginia University

View on ClinicalTrials.gov

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

Interventions

OTHER

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.

OTHER

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