to find the effectiveness of giving intravenous fluid as precaution on improving dehydration, decreasing treatment complications, and improving treatment completion rates in patients undergoing simultaneous chemotherapy and radiation therapy for head and neck cancer.

Phase 2

Recruiting

Conditions: Malignant neoplasms of lip, oral cavity and pharynx,

Registration Number: CTRI/2023/10/058708

Lead Sponsor: Christian Medical College Vellore

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 120

Inclusion Criteria

Patients receiving chemo-radiation therapy for head and neck cancers with curative intent.

Exclusion Criteria

Medical comorbidities like chronic kidney disease or congestive heart failure where fluid supplementation should be carefully done.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion of 5 or more cycles of concurrent chemoradiotherapy with no or less than 3 days of break.	Weekly assessment during the course of RT

Secondary Outcome Measures

Name	Time	Method
a) Incidence of grade 3 radiation mucositis	b) Time to onset of grade 3 radiation mucositis

Trial Locations

Locations (1): Christian Medical College, Vellore
🇮🇳
Vellore, TAMIL NADU, India
Christian Medical College, Vellore
🇮🇳Vellore, TAMIL NADU, India
Dr Balukrishna S
Principal investigator
9626262296
balunair@cmcvellore.ac.in