Enteral Feeding for Head and Neck Cancer Patients Clinical Trial
Official title:
A Randomized Comparison of Enteral Feeding for Head and Neck (HNC) Cancer Patients
| Verified date | June 2016 |
| Source | University Health Network, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Health Network, Toronto |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of Life questionnaire: Enteric Feeding (QOL-EF) | A 20-item specific questionnaire scored using individual items from 1=not at all to 5=very much | 1 year | No |
| Secondary | Evaluation of post-procedure pain associated with the use of feeding tubes | Visual analog scale | 1 year | No |
| Secondary | Quality of Life questionnaire: M.D.Anderson Swallowing Inventory (MDADI) | A self-reported utility consisting of 20 discrete 5-level items rated from "strongly agree" to "strongly disagree" | 1 year | No |
| Secondary | Patient weight loss associated with the use of feeding tubes | weight will be measured at protocol-determined time points | 2 years | No |
| Secondary | Quality of Life questionnaire: Functional Assessment of Cancer Therapy (FACT-HN) | •Quality of life as measured by Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) ranking 24 individual items from 0= not at all to 4 = very much | 1 year | No |
| Secondary | Symptoms associated with the use of feeding tubes (as per CTCAE v4 criteria) | Clinical toxicities will be grade according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4), a well known toxicity grading scale from 0 (asymptomatic) to 5 (death) | 1 year | No |