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.

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. - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058708

Enrollment

120

Registered

2023-10-16

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Normal Saline group: 500 ml of Normal saline administered over 1 hour intravenously from day 1 to the last day of radiation except on the days of hospital admissions. IV fluid administr

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Completion of 5 or more cycles of concurrent chemoradiotherapy with no or less than 3 days of break. Timepoint: Weekly assessment during the course of RT	—

Secondary

Measure	Time frame
a) Incidence of grade 3 radiation mucositis b) Time to onset of grade 3 radiation mucositis c) Duration of grade 3 radiation mucositis d) Requirement of NG/FG tube placement after initiation of treatment e) Incidence of radiation breaks of > 3 days due to morbidity f) Incidence of unplanned hospital admissionsTimepoint: Weekly assessment during the course of RT	—

Countries

India

Contacts

Public ContactDr Balu Krishna S

Christian Medical College

balunair@cmcvellore.ac.in9626262296

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026