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

Head and Neck Neoplasms Clinical Trial

— PRONUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01985438
• Other study ID #: SKMCHRC-IRB-13-15
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2013
• Last updated: December 11, 2013
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2013
• Source: Shaukat Khanum Memorial Cancer Hospital & Research Centre
• Contact: Waleed Zafar, MBBS, ScD
• Phone: +92-42-3590-5000
• Email: waleedz[@]skm.org.pk
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Shaukat Khanum Memorial Cancer Hospital and Research Center	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Shaukat Khanum Memorial Cancer Hospital & Research Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Clinical Complications	Rate of minor and major clinical complications related to placement of PEG or NG tube will be assessed	up to 24 weeks	Yes
Secondary	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	No