Head and Neck Neoplasms Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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