Feeding Tube in Cancer Patients

NCT ID: NCT02675673

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-09-30

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.

Conditions

Enteral Feeding for Head and Neck Cancer Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

GJ-Tube arm

Patients randomized to his arm would usually have a small tube is inserted through the nose into the stomach first, so that air can be used to fill the stomach to make it visible on X-ray. A fine needle is then used to inject freezing medicine (local anesthetic) into the skin of the abdomen. Using an x-ray machine for guidance, a puncture is made into the stomach through the frozen skin. The feeding tube is placed through this puncture into the stomach and the tube tip is placed in the small bowel. Once the GJ-tube has been inserted, the tube in the nose is removed.

Group Type: ACTIVE_COMPARATOR

GJ-Tube

Intervention Type: PROCEDURE

Insertion of a GJ tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.

G-Tube arm

Patients who are randomized to this arm will usually have a small tube is inserted through the nose into the stomach first, so that air can be used to fill the stomach to make it visible on X-ray. A fine needle is then used to inject freezing medicine (local anesthetic) into the skin of the abdomen. Using an x-ray machine for guidance, a puncture is made through the frozen skin. A small guiding tube or catheter is placed through this puncture into the stomach, and is advanced up the esophagus and out of the mouth. The feeding tube is then pulled into the mouth, down the esophagus, and positioned through the abdomen with its inside tip in the stomach.

Group Type: ACTIVE_COMPARATOR

G-Tube

Intervention Type: PROCEDURE

Insertion of a G-tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.

Interventions

GJ-Tube

Insertion of a GJ tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.

Intervention Type: PROCEDURE

G-Tube

Insertion of a G-tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jolie Ringash, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Other Identifiers

UHN REB 08-0393-CE

Identifier Type: -

Identifier Source: org_study_id