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NCT07784855

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

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Eligibility criteria expanded, about 8 words
    • Start date: Oct 2026 to Nov 2026
    • Site details revised at 6 of 6 sites
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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

Secondary (7)

Incidences of Individual Treatment-Related Toxicities of Interest
Incidence of Enteric Tube Placement
Incidence of Hematologic Toxicities
Residual Grade of Toxicities of Interest at 3 Months
Residual grade of Toxicities of Interest at 6 Months
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Complete Recovery of Toxicities of Interest at 3 Months
Complete Recovery of Toxicities of Interest at 6 Months

Arms and interventions

Scheduled IV HydrationExperimental

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.

Clinician Assessment-Based IV HydrationOther

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.

Other: Scheduled IV Hydration, Clinician Assessment-Based IV Hydration

Sites

6 sites in 1 country