Clinical trial NCT01985438: A Trial Comparing Two Modalities of Prophylactic Nutritional Support During Treatment for Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: Head and Neck Neoplasms
Nutritional Support
Randomized Controlled Trial
Percutaneous Endoscopic Gastrostomy tube
Nasogastric tube
Radiation Effects
Pakistan
Lead sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.


Eligibility 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.

Primary outcomes:
measure: Nutritional Status
timeFrame: change from baseline nutritional status at 24 weeks after starting treatment
Secondary outcomes:
measure: Quality of Life + Mental/Emotional health
timeFrame: change from baseline quality of life & mental/emotional health scores at 12 and 24 weeks
measure: Cost of care
timeFrame: up to 24 weeks
measure: Clinical Complications
timeFrame: up to 24 weeks
measure: Nutritional status
timeFrame: change in nutritional status from baseline at 12 weeks after starting treatment
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaukat Khanum Memorial Cancer Hospital and Research Center
state: Punjab
Study officials:
affiliation: Shaukat Khanum Memorial Cancer Hospital and Research Center
name: M. Aasim Yusuf, MBBS, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaukat Khanum Memorial Cancer Hospital and Research Center
name: Waleed Zafar, MBBS, ScD
role: PRINCIPAL_INVESTIGATOR
References: