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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Scheduled IV Hydration — OTHER
  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 — OTHER
  IV fluids (normal saline (0.9% sodium chloride)) only as clinically indicated and ordered by their treating clinician, per standard of care.

Study Details

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.

Key Dates

First listed

Aug 25, 2026

Start date

Oct 31, 2026

Status verified

Aug 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

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

• Nina Moore
  304-293-2991
  [email protected]
• Ella Betler
  304-293-4273
  [email protected]

Locations (6)

Find similar trials in Bridgeport, WV

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