A randomized control trial assessing the benefit of daily prophylactic IV fluids in patients with head and neck cancer undergoing chemoradiotherapy in a radical or adjuvant treatment setting.

Head and neck cancer patients receiving chemo-radiation therapy often develop side effects like oral cavity mucositis, dry mouth, difficulty in swallowing and jaw stiffness leading to poor oral intake and dehydration. Symptomatic dehydration during radiation therapy results in patients requiring additional interventions such as NG/FG tube placements, unplanned hospital admissions which often results in breaks in treatment and non-completion of planned course of chemo-radiation therapy. Poor treatment compliance in turn negatively affects the oncologic and survival outcomes.

An ideal preventive measure should substantially decrease the need for medical intervention and unplanned hospital admissions, while also being inexpensive, non- invasive, and easily available in clinical practice. Prophylactic daily intravenous fluid supplementation is a relatively cost effective, non-invasive, and readily accessible technique that can compensate for the background dehydration that exists in these patients. An earlier study (IRB Min. No. 12483 dated 18.12.2019) done in CMC Vellore, Radiation Oncology Unit 2 has shown a trend towards benefit of this intervention with a subset of patients receiving chemoradiotherapy showing the greatest benefit. Hence, for establishing this intervention and its benefit we plan to recruit patients on chemo- radiation therapy for head and neck cancers in a randomized controlled trial. The intervention group would be given 500 mL of normal saline daily during the course of their radiation treatment. The outcome factors such as incidence, time to onset and duration of grade 3 radiation mucositis, requirement of interventions and treatment compliance in terms of radiation breaks, unplanned admissions and completion of therapy will be compared against the control group who will not receive the intervention.