Clinical trial NCT02675673: Feeding Tube in Cancer Patients
Official title: A Randomized Comparison of Enteral Feeding for Head and Neck (HNC) Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Enteral Feeding for Head and Neck Cancer Patients
Keywords: Enteral Feeding
G-Tube
GJ Tube
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the quality of life (QOL) in head and neck patients who are given the GJ tube (which is placed in the bowel) versus those who are given the G-Tube (which is placed in the stomach) for prophylactic feeding. The standard of care for patients at Princess Margaret Hospital (PMH) is using GJ tubes. Patients who agree to be in the study will be randomized to either the GJ-Tube or the G-Tube arm. Patients randomized to the G-tube will receive prophylactic intravenous and oral antibiotics prior to insertion of the G-tube. Antibiotics will be given for a total of 1 week. A few hours following tube insertion (on return to PMH ward), patients will complete a single item, visual analogue pain scale (VAS). Patients will remain in hospital for a minimum of 24 hours and until the patient and/or family is able to care for the Enteric Feeding(EF) device at home. Patients randomized to the GJ-Tube may receive i.v medication during the procedure. All Patients will be asked to fill out several questionnaires at different time- points of the study. All Patients will have regular assessments to evaluate their overall quality of Life, toxicity, and how they respond to treatment during the study. Patients will also be assessed after they completed study treatment.

Detailed description: Prophylactic enteral feeding tubes are used routinely for nutritional support during intensive radiotherapy or chemoradiotherapy for locally advanced head and neck cancer. Typically, tubes remain in place for up to 3-4 months. Whether small-bore jejunal (GJ) or larger bore gastric (G) tubes are used varies geographically, based on tradition, physician preference and availability of services. Feeding tube placement is arranged either prior to the start of RT, or more commonly within the first 2 weeks of RT, prior to the onset of severe mucositis. Patients are admitted to hospital for 1-3 days to monitor side effects of the procedure, and to allow our dietetic and nursing staff to provide intensive teaching on the use and care of the tube. Feeding tubes are kept in place through the treatment course and removed once patients are able to meet their calorie needs and maintain body weight through oral feeding. On average, feeding tubes are removed approximately 2-3 months after completion of RT; however, approximately 20% of patients may still require enteral feeding at 1 year post-treatment. This study will compare the QOL in patients who use the G tube versus the GJ tube.

Eligibility criteria: Inclusion Criteria:

* local regional carcinoma of the oral cavity, pharynx, paranasal sinuses, larynx, cervical esophagus
* patients who will receive potentially curative radiotherapy or chemotherapy
* patients who are recommended for prophylactic enteral feeding

Exclusion Criteria:

* patients who are unable to give consent
* patients who have other concurrent active cancer diagnosis
* patients with established pharyngeal obstruction and/or presence of an EF device

Primary outcomes:
measure: Quality of Life questionnaire: Enteric Feeding (QOL-EF)
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of post-procedure pain associated with the use of feeding tubes
timeFrame: 1 year
measure: Quality of Life questionnaire: M.D.Anderson Swallowing Inventory (MDADI)
timeFrame: 1 year
measure: Patient weight loss associated with the use of feeding tubes
timeFrame: 2 years
measure: Quality of Life questionnaire: Functional Assessment of Cancer Therapy (FACT-HN)
timeFrame: 1 year
measure: Symptoms associated with the use of feeding tubes (as per CTCAE v4 criteria)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: Jolie Ringash, MD
role: PRINCIPAL_INVESTIGATOR
References: