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

Condition(s) targeted: Head and Neck Neoplasms

Intervention: percutaneous endoscopic gastrostomy tube placement (Procedure); nasogastric tube placement (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Shaukat Khanum Memorial Cancer Hospital & Research Centre

Official(s) and/or principal investigator(s):
M. Aasim Yusuf, MBBS, FRCP, Principal Investigator, Affiliation: Shaukat Khanum Memorial Cancer Hospital and Research Center
Waleed Zafar, MBBS, ScD, Principal Investigator, Affiliation: Shaukat Khanum Memorial Cancer Hospital and Research Center

Overall contact:
Waleed Zafar, MBBS, ScD, Phone: +92-42-3590-5000, Ext: 4245, Email: waleedz@skm.org.pk

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.

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

Primary outcome: Nutritional Status

Secondary outcome:

Quality of Life + Mental/Emotional health

Cost of care

Clinical Complications

Nutritional status

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Waleed Zafar, MBBS, ScD, Phone: +92-42-3590-5000, Ext: 4245, Email: waleedz@skm.org.pk

Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Punjab, Pakistan; Recruiting
Waleed Zafar, MBBS, ScD, Phone: +92 42 35905000, Ext: 4245, Email: waleedz@skm.org.pk
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, Principal Investigator
Hala Mansoor, MBBS, FCPS, Sub-Investigator
M. Adnan Masood, MBBS, FCPS, Sub-Investigator

Starting date: November 2013
Last updated: December 11, 2013