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

Head and Neck Neoplasms research study

What is the primary objective of this study?

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

Who is eligible to participate?

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 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Head and Neck Neoplasms

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:percutaneous endoscopic gastrostomy tube placementA 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 placementAll 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

percutaneous endoscopic gastrostomy tubePercutaneous 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 tubeNasogastric 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.

Study Status

Unknown status

Start Date: November 2013

Completed Date: June 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Nutritional Status

Secondary Outcome: Quality of Life + Mental/Emotional health

Study sponsors, principal investigator, and references

Principal Investigator: M. Aasim Yusuf, MBBS, FRCP

Lead Sponsor:

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01985438

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