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

NCT07784855 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-08-25

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinoma of Hypopharynx
  • Squamous Cell Carcinoma of Larynx
  • Squamous Cell Carcinoma of Oropharynx
  • Squamous Cell Carcinoma of Oral Cavity

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.

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Sidra Najeeb, MD · WVU Cancer Center

  • David Clump, MD, PhD · WVU Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784855 on ClinicalTrials.gov