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

NCT01985438 | Unknown

• 1 other identifier: SKMCHRC-IRB-13-15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Head and Neck Neoplasms

Keywords

Head and Neck Neoplasms; Nutritional Support; Randomized Controlled Trial; Percutaneous Endoscopic Gastrostomy tube; Nasogastric tube; Radiation Effects; Pakistan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of Life + Mental/Emotional health

  change from baseline quality of life & mental/emotional health scores at 12 and 24 weeks

• Cost of care

  up to 24 weeks

• Clinical Complications

  up to 24 weeks

• Nutritional status

  change in nutritional status from baseline at 12 weeks after starting treatment

Study Arms (2)

percutaneous endoscopic gastrostomy tube

ACTIVE COMPARATOR

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

nasogastric tube

ACTIVE COMPARATOR

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

Interventions

percutaneous endoscopic gastrostomy tube placement PROCEDURE

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.

percutaneous endoscopic gastrostomy tube

nasogastric tube placement PROCEDURE

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.

nasogastric tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre: lead

Study Sites (1)

Shaukat Khanum Memorial Cancer Hospital and Research Center

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waleed Zafar, MBBS, ScD

CONTACT

+92-42-3590-5000; waleedz@skm.org.pk

M. Aasim Yusuf, MBBS, FRCP

CONTACT

+92-42-3590-5000; aasim@skm.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 15, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

PA (1)