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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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* ECOG 0-2
* Non-nasopharyngeal squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx primary
* Planned for concurrent chemoradiotherapy (CCRT) with standard-of-care cisplatin-based regimen (IV cisplatin 100mg/m2 once every three weeks for up to three doses or IV cisplatin 40mg/m2 weekly) with concurrent radiotherapy (treatment duration approximately 6-7 weeks, per institutional standards).
* The use of immunotherapy in combination with CCRT is permitted and does not affect eligibility or group assignment.

Exclusion Criteria:

* Nasopharyngeal squamous cell carcinomas, nasal cavity and paranasal sinus squamous cell carcinomas.
* History of congestive heart failure.
* Dependency on enteral nutrition and hydration prior to enrollment.
* Use of diuretics that cannot be safely held during study treatment (participants who are able to temporarily discontinue diuretics during treatment are eligible).

About the study

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.

What is being tested

• Scheduled IV Hydration (other)
• Clinician Assessment-Based IV Hydration (other)

Sponsor: West Virginia University · Participants: 180 · Started: 2026-11

Contact the study team

• Nina Moore · Phone: 304-293-2991
• Ella Betler · Phone: 304-293-4273

Official record on ClinicalTrials.gov — NCT07784855

Locations in the U.S.

Conditions

• Head and Neck Squamous Cell Carcinoma

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.