Esophageal NeoplasmsNCT01870817
Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy
A study testing Home jejunostomy feeding in people with Esophageal Neoplasms, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Home jejunostomy feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Aug 2014
- 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
- planned esophagectomy or total gastrectomy for adenocarcinoma or squamous carcinoma
- suitable for home enteral nutrition
Who cannot join
- inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW
About this study
Official title: A Pilot Study Investigating the Effect of Post-operative Home Jejunostomy Feeding on Quality of Life and Nutritional Parameters in Patients With Oesophago-gastric Cancer
After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in hospital. Current practice is to stop feeding once the patient leaves hospital, although the tube is left in place for the first 6 weeks. Most patients lose weight after surgery and have to learn to adjust to new eating habits and behaviours. A few patients have the JEJ feed restarted because of nutritional problems and this requires a further inpatient stay.
It is unknown whether every patient would benefit from this type of feeding at home. Previous studies have only assessed the value of JEJ feeding while patients are still in hospital. There is little known about the benefit of continuing JEJ feeding after discharge from hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke).
Read more
The proposed study will provide initial information on patients' well being by measuring quality of life and factors such as change in body weight and dietary intake following a period of home JEJ feeding after surgery. Subjects recruited into the study will be placed, randomly, into a control group who receive current nutritional care (based on dietary advice and oral nutritional supplement drinks) or an intervention group who will receive home JEJ feeding for 6 weeks after hospital discharge, in addition to current treatment.
If subjects in the control group are experiencing problems eating at home, home feeding through the JEJ tube will be started as needed.
The study will also examine how surgery and JEJ feeding at home impact on the patient and carer(s) by means of questionnaires and interviews conducted in the patients' home.
Information obtained will assist in the design of a multicentre study. This intervention is considered important because it has the potential to benefit thousands of patients each year at a modest cost.
- Conditions
- Esophageal Neoplasms
- Being tested
- Home jejunostomy feeding
- Keywords
- Randomized, Jejunostomy, Enteral, Nutrition, Esophagectomy, Gastrectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home jejunostomy feedingDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Home jejunostomy feeding | Active comparator | Six weeks of post hospital discharge home enteral feeding Receives: Dietary Supplement: Home jejunostomy feeding |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment and retention rates
This pilot study will inform the design and planning of a larger multi-centre study
Measured: 7 months
Secondary outcomes (10)
Quality of life
Variability in disease specific and generic quality of life measures will be assessed
Measured: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Absolute body weight
Measured: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Health economics
Estimates of healthcare costs for the duration of the study will be calculated
Measured: 7 months
Readmission rates
Readmission rate to hospital during the study period
Measured: 7 months
Qualitative analysis
Interviews will be conducted with up to 10 participants and their carers \& thematic qualitative analysis of interviews performed
Measured: 8 weeks
Food intake
Self-completed 3 day food diaries will be assessed
Measured: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Body mass index
Measured: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Mid arm circumference
Measured: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Triceps fold thickness
Measured: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Grip strength
Measured: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, University of Sheffield, University of Warwick
- Responsible party
- Sponsor
- Investigators
- David J Bowrey, MD, Study director, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870817
- Sponsor's protocol ID
- 34769
- Other IDs
- PB-PG-0610-22480, 12447
- Status last verified
- Dec 2014
- First submitted
- 28 May 2013
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baker ML, Halliday V, Robinson P, Smith K, Bowrey DJ. Nutrient intake and contribution of home enteral nutrition to meeting nutritional requirements after oesophagectomy and total gastrectomy. Eur J Clin Nutr. 2017 Sep;71(9):1121-1128. doi: 10.1038/ejcn.2017.88. Epub 2017 Jun 28.
PubMed 28656968Bowrey DJ, Baker M, Halliday V, Thomas AL, Pulikottil-Jacob R, Smith K, Morris T, Ring A. A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study. Trials. 2015 Nov 21;16:531. doi: 10.1186/s13063-015-1053-y.
PubMed 26590903Bowrey DJ, Baker M, Halliday V, Thomas AL, Pulikottil-Jacob R, Smith K. Six weeks of home enteral nutrition versus standard care after esophagectomy or total gastrectomy for cancer: study protocol for a randomized controlled trial. Trials. 2014 May 24;15:187. doi: 10.1186/1745-6215-15-187.
PubMed 24885032
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Effect of Post-operative Home Jejunostomy Feeding on Quality of Life and Nutritional Parameters in Patients With Oesophago-gastric Cancer
- ClinicalTrials.gov ID
- NCT01870817
- Acronym / sponsor ID
- 34769
- Conditions
- Esophageal Neoplasms
- Keywords
- Randomized, Jejunostomy, Enteral, Nutrition, Esophagectomy, Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- University of Leicester, University of Sheffield, University of Warwick
- Study start
- Jul 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Jun 2013 (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.
After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in hospital. Current practice is to stop feeding once the patient leaves hospital, although the tube is left in place for the first 6 weeks. Most patients lose weight after surgery and have to learn to adjust to new eating habits and behaviours. A few patients have the JEJ feed restarted because of nutritional problems and this requires a further inpatient stay.
It is unknown whether every patient would benefit from this type of feeding at home. Previous studies have only assessed the value of JEJ feeding while patients are still in hospital. There is little known about the benefit of continuing JEJ feeding after discharge from hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke).
The proposed study will provide initial information on patients' well being by measuring quality of life and factors such as change in body weight and dietary intake following a period of home JEJ feeding after surgery. Subjects recruited into the study will be placed, randomly, into a control group who receive current nutritional care (based on dietary advice and oral nutritional supplement drinks) or an intervention group who will receive home JEJ feeding for 6 weeks after hospital discharge, in addition to current treatment.
If subjects in the control group are experiencing problems eating at home, home feeding through the JEJ tube will be started as needed.
The study will also examine how surgery and JEJ feeding at home impact on the patient and carer(s) by means of questionnaires and interviews conducted in the patients' home.
Information obtained will assist in the design of a multicentre study. This intervention is considered important because it has the potential to benefit thousands of patients each year at a modest cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home jejunostomy feeding | Active comparator | Dietary Supplement: Home jejunostomy feedingSix weeks of post hospital discharge home enteral feeding |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- planned esophagectomy or total gastrectomy for adenocarcinoma or squamous carcinoma
- suitable for home enteral nutrition
Key exclusion criteria (1 listed)
- inability to provide written informed consent
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 |
|---|---|---|
| Home jejunostomy feeding | Dietary supplement | Home jejunostomy feeding |
Primary outcome
Participant recruitment and retention rates
Time frame: 7 months
This pilot study will inform the design and planning of a larger multi-centre study
10 secondary outcomes
Quality of life
Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Health economics
Time frame: 7 months
Readmission rates
Time frame: 7 months
Qualitative analysis
Time frame: 8 weeks
Food intake
Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Derived from this study: PubMed 28656968Baker ML, Halliday V, Robinson P, Smith K, Bowrey DJ. Nutrient intake and contribution of home enteral nutrition to meeting nutritional requirements after oesophagectomy and total gastrectomy. Eur J Clin Nutr. 2017 Sep;71(9):1121-1128. doi: 10.1038/ejcn.2017.88. Epub 2017 Jun 28.
- Derived from this study: PubMed 26590903Bowrey DJ, Baker M, Halliday V, Thomas AL, Pulikottil-Jacob R, Smith K, Morris T, Ring A. A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study. Trials. 2015 Nov 21;16:531. doi: 10.1186/s13063-015-1053-y.
- Derived from this study: PubMed 24885032Bowrey DJ, Baker M, Halliday V, Thomas AL, Pulikottil-Jacob R, Smith K. Six weeks of home enteral nutrition versus standard care after esophagectomy or total gastrectomy for cancer: study protocol for a randomized controlled trial. Trials. 2014 May 24;15:187. doi: 10.1186/1745-6215-15-187.
- Published trial protocolLink provided by the sponsor.
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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.
David J Bowrey, MD study director
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home jejunostomy feeding in people with Esophageal Neoplasms, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant recruitment and retention rates (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01870817, which also lists 3 linked publications.
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 4 Dec 2014.