CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2023/10/058708 [Registered on: 16/10/2023] Trial Registered Prospectively

Last Modified On:

30/10/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

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.

Scientific Title of Study

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.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Megha T Philip
Designation	PG Registrar
Affiliation	Christian Medical College
Address	Radiation Oncology Unit II, Ida B Scudder Cancer Centre Christian Medical College Vellore TAMIL NADU 632004 India
Phone	9847375930
Fax
Email	megha.philip.pg@cmcvellore.ac.in

Details of Contact Person
Scientific Query

Name	Dr Balu Krishna S
Designation	Professor
Affiliation	Christian Medical College
Address	Radiation Oncology Unit II, Ida B Scudder Cancer Centre Christian Medical College Vellore TAMIL NADU 632004 India
Phone	9626262296
Fax
Email	balunair@cmcvellore.ac.in

Details of Contact Person
Public Query

Name	Dr Balu Krishna S
Designation	Professor
Affiliation	Christian Medical College
Address	Radiation Oncology Unit II, Ida B Scudder Cancer Centre Christian Medical College Vellore TAMIL NADU 632004 India
Phone	9626262296
Fax
Email	balunair@cmcvellore.ac.in

Source of Monetary or Material Support

Radiation Oncology Unit II, Ida B Cancer Centre, Christian Medical College, Vellore, Tamil Nadu, India. Pin: 632004

Primary Sponsor

Name	Christian Medical College Vellore
Address	Radiation Oncology Unit II, Ida B Scudder Cancer Centre, Christian Medical College, Vellore Tamil Nadu 632004
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Balukrishna S	Christian Medical College, Vellore	Radiation Oncology Unit II, Ida B Scudder Cancer Centre, Christian Medical College, Vellore Vellore TAMIL NADU	9626262296 balunair@cmcvellore.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Office of Research Institutional Research Board (IRB), Christian Medical College, Vellore, India	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C00-C14\|\|Malignant neoplasms of lip, oral cavity and pharynx,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	No Intervention	No intervention is offered to the patients
Intervention	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 administration would be done on all days of radiation and avoided on weekends when no radiation is given. Patients are encouraged to take adequate fluids orally or via nasogastric tube, while considering this IV fluid administration as a means of prophylactic supplementation.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	Patients receiving chemo-radiation therapy for head and neck cancers with curative intent.

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
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

Outcome	TimePoints
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 admissions	Weekly assessment during the course of RT

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

23/10/2023

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

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.