Enteral Feeding for Head and Neck Cancer PatientsNCT02675673
Feeding Tube in Cancer Patients
A study testing GJ-Tube and G-Tube in people with Enteral Feeding for Head and Neck Cancer Patients, run by University Health Network, Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding for Head and Neck Cancer Patients
- What is being tested?
- GJ-Tube and G-Tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Randomized Comparison of Enteral Feeding for Head and Neck (HNC) Cancer Patients
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.
Read the 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.
- Being tested
- GJ-Tube, G-Tube
- Keywords
- Enteral Feeding, G-Tube, GJ Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GJ-TubeProcedure or surgery
Insertion of a GJ tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.
G-TubeProcedure or surgery
Insertion of a G-tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.
| Study group | Role | What they receive |
|---|---|---|
| GJ-Tube arm | Active comparator | 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. Receives: Procedure: GJ-Tube |
| G-Tube arm | Active comparator | 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. Receives: Procedure: G-Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (5)
Evaluation of post-procedure pain associated with the use of feeding tubes
Visual analog scale
Measured: 1 year
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"
Measured: 1 year
Patient weight loss associated with the use of feeding tubes
weight will be measured at protocol-determined time points
Measured: 2 years
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
Measured: 1 year
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Why it stopped: Logistical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Feeding for Head and Neck Cancer PatientsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jolie Ringash, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675673
- Sponsor's protocol ID
- UHN REB 08-0393-CE
- Status last verified
- Jun 2016
- First submitted
- 11 Jun 2013
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Enteral Feeding for Head and Neck (HNC) Cancer Patients
- ClinicalTrials.gov ID
- NCT02675673
- Acronym / sponsor ID
- UHN REB 08-0393-CE
- Keywords
- Enteral Feeding, G-Tube, GJ Tube
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GJ-Tube arm | Active comparator | Procedure: GJ-TubePatients 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. |
| G-Tube arm | Active comparator | Procedure: G-TubePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GJ-TubeInsertion of a GJ tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage. | Procedure or surgery | GJ-Tube arm |
| G-TubeInsertion of a G-tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage. | Procedure or surgery | G-Tube arm |
Primary outcome
Quality of Life questionnaire: Enteric Feeding (QOL-EF)
Time frame: 1 year
A 20-item specific questionnaire scored using individual items from 1=not at all to 5=very much
5 secondary outcomes
Evaluation of post-procedure pain associated with the use of feeding tubes
Time frame: 1 year
Quality of Life questionnaire: M.D.Anderson Swallowing Inventory (MDADI)
Time frame: 1 year
Patient weight loss associated with the use of feeding tubes
Time frame: 2 years
Quality of Life questionnaire: Functional Assessment of Cancer Therapy (FACT-HN)
Time frame: 1 year
Symptoms associated with the use of feeding tubes (as per CTCAE v4 criteria)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolie Ringash, MD principal investigator
University Health Network, Princess Margaret Hospital
Questions about this trial
What is this clinical trial studying?
A study testing GJ-Tube and G-Tube in people with Enteral Feeding for Head and Neck Cancer Patients, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life questionnaire: Enteric Feeding (QOL-EF) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.