Recruiting

IV Hydration

Sponsor:

West Virginia University

Code:

NCT07784855

Conditions

Squamous Cell Carcinoma of Hypopharynx

Squamous Cell Carcinoma of Larynx

Squamous Cell Carcinoma of Oropharynx

Squamous Cell Carcinoma of Oral Cavity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Scheduled IV Hydration

Clinician Assessment-Based IV Hydration

Study Details

Brief 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

Study ID

NCT07784855

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Scheduled IV Hydration

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.

other: 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.

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.

Primary outcome measure

  • Incidence of at least one Grade ≥3 Treatment-Related Toxicities of Interest [ Time Frame: From initiation of concurrent chemoradiotherapy through completion of treatment (approximately 6-7 weeks) ]

Central Contacts and Locations

Central contacts

Nina Moore

304-293-2991nina.moore@hsc.wvu.edu

Ella Betler

304-293-4273eibetler@hsc.wvu.edu

Locations

West Virginia University Cancer Institute

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Nina Moore

304-293-2991nina.moore@hsc.wvu.edu

Ella Betler

304-293-4273eibetler@hsc.wvu.edu

Principal Investigator:

Sidra Najeeb, MD

More Information

Sponsor

West Virginia University

Last update posted

Nov 13, 2026

Last verified

Oct, 2026

Keywords

  • Treatment related toxicities
  • IV hydration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by West Virginia University on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.