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

Not Applicable

• Conditions: Head and Neck Neoplasms
• Interventions: Procedure: percutaneous endoscopic gastrostomy tube placement; Procedure: nasogastric tube placement

• Registration Number: NCT01985438
• Lead Sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All treatment-naïve patients presenting to the Head and Neck outpatient Clinic at Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore AND accepted into the system for treatment of a primary malignant neoplasm of head and neck (neoplasms of lip; oral cavity; pharynx; and larynx [see appendix for detailed definition and corresponding International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) codes] AND referred to the Gastroenterology (GI) service for percutaneous endoscopic gastrostomy tube placement or nasogastric tube placement
• 18 years or older

Exclusion Criteria

• Patients who have already received treatment for the neoplasm of head and neck at a center other than SKMCH&RC.
• Patients with recurrence following earlier treatment for cancer of the head and neck region.
• Patients presenting with neoplasms of nasal cavities, middle ear and accessory sinuses; skin of head, neck and face; neoplasms of eye; and neoplasms of brain.
• Patients with contraindications to PEG tube or NG tube placement.
• Patients with moderate to severe mental or physical disabilities because such disabilities will make it impossible to assess functional status deterioration related to the disease or its treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous endoscopic gastrostomy tube	percutaneous endoscopic gastrostomy tube placement	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
nasogastric tube	nasogastric tube placement	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.

Primary Outcome Measures

Name	Time	Method
Nutritional Status	change from baseline nutritional status at 24 weeks after starting treatment	Nutritional status will be assessed using three methods: (1) Patient-Generated Subjective Global Assessment (PG-SGA) tool, (2) anthropometric data, and (3) biochemical data. Biochemical assessment will be done by measuring serum albumin and electrolytes and kidney function tests. Primary outcome will be analyzed at aggregate level and after stratifying by age, sex, location of tumor, disease severity, and grade of dysphagia.

Secondary Outcome Measures

Name	Time	Method
Quality of Life + Mental/Emotional health	change from baseline quality of life & mental/emotional health scores at 12 and 24 weeks	The quality of life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) version 3.0. and Functional Assessment of Cancer Therapy Head and Neck (FACT H\&N) version 4. Patients will also be assessed for their mental and emotional health. For this purpose, Hospital Anxiety and Depression Scale (HADS) will be used. All of these questionnaires are available in Urdu.
Cost of care	up to 24 weeks	Data on cost of care associated with nutritional support will be assessed from the hospital's and patient's perspective.
Clinical Complications	up to 24 weeks	Rate of minor and major clinical complications related to placement of PEG or NG tube will be assessed
Nutritional status	change in nutritional status from baseline at 12 weeks after starting treatment	Nutritional status will be assessed using three methods: (1) Patient-Generated Subjective Global Assessment (PG-SGA) tool, (2) anthropometric data, and (3) biochemical data. Biochemical assessment will be done by measuring serum albumin and electrolytes and kidney function tests. All secondary outcomes will be analyzed at aggregate level and after stratifying by age, sex, location of tumor, disease severity, and grade of dysphagia.

Trial Locations

Locations (1)

Shaukat Khanum Memorial Cancer Hospital and Research Center; 🇵🇰 Lahore, Punjab, Pakistan