A Trial Comparing Two Modalities of Prophylactic Nutritional Support During Treatment for Head and Neck Cancer

Summary

Purpose:

To compare the effect of prophylactic enteral feeding tube placement (either percutaneous endoscopic gastrostomy (PEG) tube or nasogastric (NG) tube) in patients undergoing treatment for head and neck cancer (HNC) on nutritional status, quality of life, mental and emotional health, rates of clinical complications, and cost of care.

Study Design:

Prospective randomized controlled trial with 2 arms and equal allocation ratio

Study Objectives:

1. The primary objective is to assess, among HNC patients randomized to receive either prophylactic PEG tube or NG tube for enteral support and who are undergoing chemo-radiation at SKMCH\&RC, the change from baseline in nutritional status at the end of 24 weeks after treatment initiation.
2. The secondary objectives are to assess, among HNC patients randomized to receive either prophylactic PEG tube or NG tube for enteral support and who are undergoing chemo-radiation at SKMCH\&RC, the change from baseline in nutritional status at the end of 12 weeks; the rates of complications; quality of life including symptoms of depression and anxiety; and cost of care (all related to enteral feeding tube placement only) at baseline and at the end of 12 weeks and 24 weeks after treatment initiation.

Patients and methods:

Eligible patients will be enrolled consecutively from the gastroenterology outpatient clinics at Shaukat Khanum Memorial Cancer Hospital and Research Center (SKMCH\&RC), Lahore and randomly assigned to receive either PEG tube or NG tube placement prior to commencement of treatment. Patients will receive counseling from a trained nutritionist regarding adequate nutrition during treatment and enteral feeding tube care. Detailed information regarding demographics, cancer location, type and staging, clinical status, nutritional status, quality of life, mental and emotional health, and cost of care will be obtained at baseline (time at which cancer treatment is initiated) and on 21st day (3 weeks), 42nd day (6 weeks), 84th day (12 weeks) and 168th day (24 weeks) after initiating chemoradiation. The primary endpoint will be to compare the nutritional status between the two treatment groups on an intent-to-treat basis on 168th day (24 weeks) after initiating chemoradiation.

Conditions

• Head and Neck Neoplasms

Interventions

PROCEDURE

percutaneous endoscopic gastrostomy tube placement

A 20 Fr PEG tube (Cook Medical, or Boston Scientific) will be placed endoscopically using Ponsky's pull technique, under conscious sedation, as a day-case procedure. A single dose of a prophylactic intravenous antibiotic (1.2g co-amoxiclav, 30 minutes prior to the procedure, unless evidence of penicillin allergy) will be given to all patients undergoing PEG tube insertion. Patients will be monitored for one hour prior to discharge following PEG tube insertion.

PROCEDURE

nasogastric tube placement

All nasogastric tubes will be inserted in a standard manner by a Gastroenterology Fellow or an Internal Medicine resident. Ordinarily, a 14 Fr, fine-bore NG feeding tube will be inserted at the bedside or, if unsuccessful, inserted under radiological guidance. A post-procedure abdominal x-ray will be performed to confirm correct placement of all NG tubes.

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre

  lead OTHER

Principal Investigators

• M. Aasim Yusuf, MBBS, FRCP · Shaukat Khanum Memorial Cancer Hospital and Research Center

• Waleed Zafar, MBBS, ScD · Shaukat Khanum Memorial Cancer Hospital and Research Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• Pakistan

Study Locations