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

Prophylactic Nutritional Support During Treatment for Head and Neck Cancer: A Single-Center, Open-label, Prospective, Randomized, Controlled Trial Comparing Feeding With Percutaneous Endoscopic Gastrostomy Tubes and Nasogastric Tubes

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.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Procedure: percutaneous endoscopic gastrostomy tube placement; Procedure: nasogastric tube placement

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Recruiting
      • Shaukat Khanum Memorial Cancer Hospital and Research Center
      • Contact: Waleed Zafar, MBBS, ScD; Phone Number: 4245 +92 42 35905000; Email: waleedz@skm.org.pk
      • Principal Investigator: M. Aasim Yusuf, MBBS, FRCP
      • Principal Investigator: Waleed Zafar, MBBS, ScD
      • Principal Investigator: Arif Jamshed, MBBS, FRCR
      • Principal Investigator: M. Qayyum Khan, MBBS, MRCP
      • Principal Investigator: Syed R Hussain, MBBS, FDSRCS
      • Principal Investigator: Faisal Zeb, MBBS, MRCPS
      • Sub-Investigator: Hala Mansoor, MBBS, FCPS
      • Sub-Investigator: M. Adnan Masood, MBBS, FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: percutaneous endoscopic gastrostomy tube; 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: 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.
ACTIVE_COMPARATOR: nasogastric tube; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Status	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.	change from baseline nutritional status at 24 weeks after starting treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life + Mental/Emotional health	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.	change from baseline quality of life & mental/emotional health scores at 12 and 24 weeks
Cost of care	Data on cost of care associated with nutritional support will be assessed from the hospital's and patient's perspective.	up to 24 weeks
Clinical Complications	Rate of minor and major clinical complications related to placement of PEG or NG tube will be assessed	up to 24 weeks
Nutritional status	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.	change in nutritional status from baseline at 12 weeks after starting treatment

Collaborators and Investigators

• Sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
• Investigators: Principal Investigator: M. Aasim Yusuf, MBBS, FRCP, Shaukat Khanum Memorial Cancer Hospital and Research Center; Principal Investigator: Waleed Zafar, MBBS, ScD, Shaukat Khanum Memorial Cancer Hospital and Research Center

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ANTICIPATED): June 1, 2015
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (ESTIMATE): November 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Head and Neck Neoplasms; Nasogastric tube; Pakistan; Nutritional Support; Percutaneous Endoscopic Gastrostomy tube; Radiation Effects
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: SKMCHRC-IRB-13-15