Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Shaukat Khanum Memorial Cancer Hospital & Research Centre
Sponsor:
Information provided by (Responsible Party):
Shaukat Khanum Memorial Cancer Hospital & Research Centre
ClinicalTrials.gov Identifier:
NCT01985438
First received: November 1, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Head and Neck Neoplasms
Procedure: percutaneous endoscopic gastrostomy tube placement
Procedure: nasogastric tube placement

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

Resource links provided by NLM:


Further study details as provided by Shaukat Khanum Memorial Cancer Hospital & Research Centre:

Primary Outcome Measures:
  • Nutritional Status [ Time Frame: change from baseline nutritional status at 24 weeks after starting treatment ] [ Designated as safety issue: No ]
    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:
  • Quality of Life + Mental/Emotional health [ Time Frame: change from baseline quality of life & mental/emotional health scores at 12 and 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Data on cost of care associated with nutritional support will be assessed from the hospital's and patient's perspective.

  • Clinical Complications [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
    Rate of minor and major clinical complications related to placement of PEG or NG tube will be assessed

  • Nutritional status [ Time Frame: change in nutritional status from baseline at 12 weeks after starting treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985438

Contacts
Contact: Waleed Zafar, MBBS, ScD +92-42-3590-5000 ext 4245 waleedz@skm.org.pk
Contact: M. Aasim Yusuf, MBBS, FRCP +92-42-3590-5000 ext 4002 aasim@skm.org.pk

Locations
Pakistan
Shaukat Khanum Memorial Cancer Hospital and Research Center Recruiting
Lahore, Punjab, Pakistan
Contact: Waleed Zafar, MBBS, ScD    +92 42 35905000 ext 4245    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         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Shaukat Khanum Memorial Cancer Hospital & Research Centre
ClinicalTrials.gov Identifier: NCT01985438     History of Changes
Other Study ID Numbers: SKMCHRC-IRB-13-15
Study First Received: November 1, 2013
Last Updated: December 11, 2013
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Shaukat Khanum Memorial Cancer Hospital & Research Centre:
Head and Neck Neoplasms
Nutritional Support
Randomized Controlled Trial
Percutaneous Endoscopic Gastrostomy tube
Nasogastric tube
Radiation Effects
Pakistan

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014