Oesophageal CancerUWLNCT05074914
Unintentional Weight Loss After Oesophagectomy
A study testing oesophagectomy in people with Oesophageal Cancer, run by University College Dublin at 1 site in Ireland.
Trial summary
The incidence of cancer of the oesophagus is increasing. While surgical removal of the tumour (oesophagectomy) may offer the best chance of cure, such major operations are associated with long-term complications such as poor appetite, unintentional weight loss and nutritional impairments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- oesophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIreland
- Study dates
- 30 Jun 2021to Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Oesophageal adenocarcinoma group:
- Planned for oesophagectomy with gastric conduit reconstruction
- Recurrence-free at least 12 months post-operatively
- Weight loss ≥10% from premorbid weight or require ongoing caloric supplementation
- Barrett's oesophagus group:
- -Barrett's oesophagus group who are under surveillance from INCEUGIN
Who cannot join
- Pregnant or breastfeeding, or planning to become pregnant
- Unable to swallow or need frequent dilatations ("stretches")
- Unable to eat semisolid food
- Allergies or dietary intolerance
- Diabetes mellitus type 1
- Reoccurrence of disease after surgery or are having another active form of cancer
Show all 14Show fewer
- Taking medication which may impact gut hormone physiology
- Unstable cardiovascular disease
- A significant neurological condition
- A previous upper gastrointestinal resection
- A medical condition that would limit the ability to take part, that might impact certain test results or might make it unsafe for the patient to take these treatments.
- Difficulty reading, understanding or remembering the information we have given.
- Previous abdominal surgery.
- Treatment with GLP-1 receptor agonists or DPP-IV inhibitor or insulin
Trial locations and contacts
1 site in 1 country.
Roshaida Abdul Wahab, MD contact
Ireland1 site, 1 recruiting
- Recruiting
St James University Hospital Clinical Research Centre
Dublin, Dublin 8
Maria Figueir, +3531 410 3900, mfigueir@tcd.ie
Carel le Roux, Pr, MD
About this study
Official title: Mechanisms and Treatment of Unintentional Weight Loss After Oesophagectomy With Curative Intent
The incidence of cancer of the oesophagus is increasing. While surgical removal of the tumour (oesophagectomy) may offer the best chance of cure, such major operations are associated with long-term complications such as poor appetite, unintentional weight loss and nutritional impairments. In the long-term, unintentional weight loss of 10-30% increases the risk of disease and death. However, a knowledge gap exists as there has been no comprehensive assessment of how this surgery changes the mechanisms of how the gut communicates with the brain (gut-brain pathways) and its relation to food intake and eating behaviour.
The aims of this study are to test the hypotheses that:
- Oesophagectomy induces changes in the small intestine barrier (gut mucosa) and changes in hormonal signals after food consumption.
- Oesophagectomy reduces appetite, eating behaviour, and food intake and shifts food selection from high-fat and high-glycaemic index items (quickly digested carbohydrates) to low-fat and low-glycaemic index items (slowly digested).
Read the detailed description
Oesophageal cancer accounts for 27,700 deaths per year in the European Union (1). Oesophagectomy is a key component of state of the art multi-modal (preoperative chemo[radio] therapy) treatment for these patients (2).
Patients may require additional chemo(radio)therapy and/ or a feeding jejunostomy for the initial period after surgery. Half of the patients remain cancer free five years after oesophagectomy (3), however many of them have unintentional weight loss as the patients involuntarily reduce food intake (4).
Prior to curative surgery, unintentional weight loss is a common presenting feature among patients with oesophageal cancer. Initially after surgery, reduced food intake may be compounded by the impact of the operation on the patient. This can be due to inflammation of the gut mucosa during chemo(radio)therapy. However, in contrast to many other operations of similar complexity, when patients recover from the surgical insult and are cured of cancer, restoration of normal food intake does not typically occur (5).
Unintentional weight loss of 10-30% (from starting weight following surgery) increases long term morbidity and mortality even in those in remission of cancer. Effective nutritional support reduces early postoperative associated morbidity but does not modify long-term oncologic outcome even when surgical techniques, tumour size, and malignant potential are standardized. Empirical support that it is possible for patients to increase their food intake voluntarily after oesophagectomy remains equivocal. The investigators don't understand why these patients, who are tumour free, suffer unintentional weight loss (4).
The existing putative aetiological factors do not fully explain continued unintentional weight loss. Initially after surgery gastric emptying is delayed, but after 6 months gastric emptying is rapid. Pancreatic exocrine insufficiency and/or small intestinal bacterial overgrowth are present in 40% of patients after oespohagectomy. A subset of patients also experiences early postprandial intestinal discomfort (dumping syndrome) after consuming refined carbohydrates. However, the severity of bacterial overgrowth, pancreatic exocrine insufficiency, or dumping syndrome does not correlate with unintentional weight loss. Moreover, treatments of these do not consistently lead to weight regain. Another potential factor, the reduction of the "hunger hormone" ghrelin after oesophagectomy does not fully explain unintentional weight loss as ghrelin recovers to baseline levels after 12-24 month and therapy with ghrelin analogues has had limited success in terms of increasing long term food intake and bodyweight. Consequently, a knowledge gap exists as to which other factors involved in the gut-brain pathway are key to the profound degree of weight loss.
The investigators will conduct a series of experiments investigating the gut, eating behaviour, and food intake in 48 patients who will be recruited from the INCOGC. These patients are all eligible for treatment with curative intent involving removal of the food pipe tumor. As a comparator group, the investigators will also recruit 16 weight stable patients under surveillance for Barrett's oesophagus (a condition that can develop into cancer in a small number of people) in the Irish National Centre for Early Upper GI Neoplasia. The study visits will be time-matched and balanced for risk-factor profile, age and gender; the comparator group will confirm that, in the absence of surgery, all end-points are temporally stable. Each subject will be studied four times. Subjects will be excluded if cancer recurrence or ongoing therapy compromises the study protocol.
All patients before and after oesophagectomy have routine endoscopy (procedure to allow examination of the food pipe) as part of standard care which will allow us to easily conduct aim 1 as fresh tissue samples from the gut will be easily obtained during this routine investigation. The initial biopsy sample (pre-intervention) will be obtained during the surgical episode in theatre so that no additional endoscopies will be required. Aim 2 is conducted on a separate day as subjects will arrive in the Clinical Research Facility after an overnight fast (water allowed). Upon arrival on each test day, weight and height will be recorded and body composition will be assessed. Subjects will be given a standard 400 kcal meal and have serial blood tests 30 minutes apart. The progressive ratio task (a simple test in which an increasing number of computer mouse clicks is needed to earn a sweet) will be conducted followed by a buffet lunch and blood and stool test. In the early afternoon subjects are allowed to go home.
Biopsies, blood and stool samples will be collected. The investigators will correlate changes in gut cells, hormones and microorganisms with changes in food preferences and eating behaviour.
- Conditions
- Oesophageal Cancer
- Being tested
- oesophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oesophagectomyProcedure or surgery
removal of oesophagus
| Study group | Role | What they receive |
|---|---|---|
| Adenocarcinoma of the oesophagus | Experimental | curative oesophagectomy Receives: Procedure: oesophagectomy |
| Barrett's oesophagus | No intervention | Weight stable patient under survelliance with Barrett's oespophagus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the change in appetitive behaviour from baseline (before oesophagectomy) until 2 years following oesophagectomy using a progressive ratio task.
measured using Progressive ratio task
Measured: 0, 6, 12 and 24 months
Direct measurement of changes in food intake from baseline (before oesophagectomy) until two years postoperatively using a standard buffet meal and weighing the specific foods before and after consumption.
weighted measurement of food consumed before and after eating
Measured: 0, 6, 12 and 24 months
Direct measurement of changes in food selection from baseline (before oesophagectomy) until two years postoperatively using a standard buffet meal and observing the specific foods selection before and after consumption.
observed measurement of food selection before and after eating
Measured: 0, 6, 12 and 24 months
Measurement of the change in postprandial gut hormone profiles from baseline (before oesophagectomy) until two years following oesophagectomy.
Measured through plasma hormone levels taken before and after food consumption
Measured: Every 30 minutes over a two hour period at 0, 6, 12 and 24 months
Measurement of the change in plasma bile acid profiles from baseline (before oesophagectomy) until two years following oesophagectomy.
Measured through plasma bile levels taken before and after food consumption
Measured: Every 30 minutes over a two hour period at 0, 6, 12 and 24 months
Measurement of the change in faecal gut microbiota from baseline (before oesophagectomy) until two years following oesophagectomy.
Measured through stool samples and observation of changes to bacteria present
Measured: Every 30 minutes over a two hour period at 0, 6, 12 and 24 months
Quantification of changes in enteroendocrine cells in the mucosa of the proximal small bowel at baseline (before oesophagectomy) until 2 years postoperatively.
Measured through biopsy
Measured: Baseline and up to 24 months postoperatively
Quantification of changes in gut microbiota in the mucosa of the proximal small bowel at baseline before oesophagectomy until 2 years postoperatively.
Measured through biopsy
Measured: Baseline and up to 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start30 Jun 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carel Le Roux, Pr, MD, Study chair, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074914
- Sponsor's protocol ID
- UWL-01
- Acronym
- UWL
- Status last verified
- Apr 2022
- First submitted
- 15 Jul 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stahl M, Mariette C, Haustermans K, Cervantes A, Arnold D; ESMO Guidelines Working Group. Oesophageal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi51-6. doi: 10.1093/annonc/mdt342. No abstract available.
PubMed 24078662Wilke TJ, Bhirud AR, Lin C. A review of the impact of preoperative chemoradiotherapy on outcome and postoperative complications in esophageal cancer patients. Am J Clin Oncol. 2015 Aug;38(4):415-21. doi: 10.1097/COC.0000000000000021.
PubMed 24351783Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.
PubMed 26254683Baker M, Halliday V, Williams RN, Bowrey DJ. A systematic review of the nutritional consequences of esophagectomy. Clin Nutr. 2016 Oct;35(5):987-94. doi: 10.1016/j.clnu.2015.08.010. Epub 2015 Sep 12.
PubMed 26411750Martin L, Lagergren P. Long-term weight change after oesophageal cancer surgery. Br J Surg. 2009 Nov;96(11):1308-14. doi: 10.1002/bjs.6723.
PubMed 19847871
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Treatment of Unintentional Weight Loss After Oesophagectomy With Curative Intent
- ClinicalTrials.gov ID
- NCT05074914
- Acronym / sponsor ID
- UWL / UWL-01
- Conditions
- Oesophageal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 12 Oct 2021 (actual)
- 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 incidence of cancer of the oesophagus is increasing. While surgical removal of the tumour (oesophagectomy) may offer the best chance of cure, such major operations are associated with long-term complications such as poor appetite, unintentional weight loss and nutritional impairments. In the long-term, unintentional weight loss of 10-30% increases the risk of disease and death. However, a knowledge gap exists as there has been no comprehensive assessment of how this surgery changes the mechanisms of how the gut communicates with the brain (gut-brain pathways) and its relation to food intake and eating behaviour.
The aims of this study are to test the hypotheses that:
- Oesophagectomy induces changes in the small intestine barrier (gut mucosa) and changes in hormonal signals after food consumption.
- Oesophagectomy reduces appetite, eating behaviour, and food intake and shifts food selection from high-fat and high-glycaemic index items (quickly digested carbohydrates) to low-fat and low-glycaemic index items (slowly digested).
Detailed description
Oesophageal cancer accounts for 27,700 deaths per year in the European Union (1). Oesophagectomy is a key component of state of the art multi-modal (preoperative chemo[radio] therapy) treatment for these patients (2).
Patients may require additional chemo(radio)therapy and/ or a feeding jejunostomy for the initial period after surgery. Half of the patients remain cancer free five years after oesophagectomy (3), however many of them have unintentional weight loss as the patients involuntarily reduce food intake (4).
Prior to curative surgery, unintentional weight loss is a common presenting feature among patients with oesophageal cancer. Initially after surgery, reduced food intake may be compounded by the impact of the operation on the patient. This can be due to inflammation of the gut mucosa during chemo(radio)therapy. However, in contrast to many other operations of similar complexity, when patients recover from the surgical insult and are cured of cancer, restoration of normal food intake does not typically occur (5).
Unintentional weight loss of 10-30% (from starting weight following surgery) increases long term morbidity and mortality even in those in remission of cancer. Effective nutritional support reduces early postoperative associated morbidity but does not modify long-term oncologic outcome even when surgical techniques, tumour size, and malignant potential are standardized. Empirical support that it is possible for patients to increase their food intake voluntarily after oesophagectomy remains equivocal. The investigators don't understand why these patients, who are tumour free, suffer unintentional weight loss (4).
The existing putative aetiological factors do not fully explain continued unintentional weight loss. Initially after surgery gastric emptying is delayed, but after 6 months gastric emptying is rapid. Pancreatic exocrine insufficiency and/or small intestinal bacterial overgrowth are present in 40% of patients after oespohagectomy. A subset of patients also experiences early postprandial intestinal discomfort (dumping syndrome) after consuming refined carbohydrates. However, the severity of bacterial overgrowth, pancreatic exocrine insufficiency, or dumping syndrome does not correlate with unintentional weight loss. Moreover, treatments of these do not consistently lead to weight regain. Another potential factor, the reduction of the "hunger hormone" ghrelin after oesophagectomy does not fully explain unintentional weight loss as ghrelin recovers to baseline levels after 12-24 month and therapy with ghrelin analogues has had limited success in terms of increasing long term food intake and bodyweight. Consequently, a knowledge gap exists as to which other factors involved in the gut-brain pathway are key to the profound degree of weight loss.
The investigators will conduct a series of experiments investigating the gut, eating behaviour, and food intake in 48 patients who will be recruited from the INCOGC. These patients are all eligible for treatment with curative intent involving removal of the food pipe tumor. As a comparator group, the investigators will also recruit 16 weight stable patients under surveillance for Barrett's oesophagus (a condition that can develop into cancer in a small number of people) in the Irish National Centre for Early Upper GI Neoplasia. The study visits will be time-matched and balanced for risk-factor profile, age and gender; the comparator group will confirm that, in the absence of surgery, all end-points are temporally stable. Each subject will be studied four times. Subjects will be excluded if cancer recurrence or ongoing therapy compromises the study protocol.
All patients before and after oesophagectomy have routine endoscopy (procedure to allow examination of the food pipe) as part of standard care which will allow us to easily conduct aim 1 as fresh tissue samples from the gut will be easily obtained during this routine investigation. The initial biopsy sample (pre-intervention) will be obtained during the surgical episode in theatre so that no additional endoscopies will be required. Aim 2 is conducted on a separate day as subjects will arrive in the Clinical Research Facility after an overnight fast (water allowed). Upon arrival on each test day, weight and height will be recorded and body composition will be assessed. Subjects will be given a standard 400 kcal meal and have serial blood tests 30 minutes apart. The progressive ratio task (a simple test in which an increasing number of computer mouse clicks is needed to earn a sweet) will be conducted followed by a buffet lunch and blood and stool test. In the early afternoon subjects are allowed to go home.
Biopsies, blood and stool samples will be collected. The investigators will correlate changes in gut cells, hormones and microorganisms with changes in food preferences and eating behaviour.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenocarcinoma of the oesophagus | Experimental | Procedure: oesophagectomycurative oesophagectomy |
| Barrett's oesophagus | No intervention | –Weight stable patient under survelliance with Barrett's oespophagus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Oesophageal adenocarcinoma group:
- Planned for oesophagectomy with gastric conduit reconstruction
- Recurrence-free at least 12 months post-operatively
- Weight loss ≥10% from premorbid weight or require ongoing caloric supplementation
- Barrett's oesophagus group:
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding, or planning to become pregnant
- Unable to swallow or need frequent dilatations ("stretches")
- Unable to eat semisolid food
- Allergies or dietary intolerance
- Diabetes mellitus type 1
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 |
|---|---|---|
| oesophagectomyremoval of oesophagus | Procedure or surgery | Adenocarcinoma of the oesophagus |
Primary outcome
Measurement of the change in appetitive behaviour from baseline (before oesophagectomy) until 2 years following oesophagectomy using a progressive ratio task.
Time frame: 0, 6, 12 and 24 months
measured using Progressive ratio task
Direct measurement of changes in food intake from baseline (before oesophagectomy) until two years postoperatively using a standard buffet meal and weighing the specific foods before and after consumption.
Time frame: 0, 6, 12 and 24 months
weighted measurement of food consumed before and after eating
Direct measurement of changes in food selection from baseline (before oesophagectomy) until two years postoperatively using a standard buffet meal and observing the specific foods selection before and after consumption.
Time frame: 0, 6, 12 and 24 months
observed measurement of food selection before and after eating
Measurement of the change in postprandial gut hormone profiles from baseline (before oesophagectomy) until two years following oesophagectomy.
Time frame: Every 30 minutes over a two hour period at 0, 6, 12 and 24 months
Measured through plasma hormone levels taken before and after food consumption
Measurement of the change in plasma bile acid profiles from baseline (before oesophagectomy) until two years following oesophagectomy.
Time frame: Every 30 minutes over a two hour period at 0, 6, 12 and 24 months
Measured through plasma bile levels taken before and after food consumption
Measurement of the change in faecal gut microbiota from baseline (before oesophagectomy) until two years following oesophagectomy.
Time frame: Every 30 minutes over a two hour period at 0, 6, 12 and 24 months
Measured through stool samples and observation of changes to bacteria present
Quantification of changes in enteroendocrine cells in the mucosa of the proximal small bowel at baseline (before oesophagectomy) until 2 years postoperatively.
Time frame: Baseline and up to 24 months postoperatively
Measured through biopsy
Quantification of changes in gut microbiota in the mucosa of the proximal small bowel at baseline before oesophagectomy until 2 years postoperatively.
Time frame: Baseline and up to 24 months postoperatively
Measured through biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Background: PubMed 24078662Stahl M, Mariette C, Haustermans K, Cervantes A, Arnold D; ESMO Guidelines Working Group. Oesophageal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi51-6. doi: 10.1093/annonc/mdt342. No abstract available.
- Background: PubMed 24351783Wilke TJ, Bhirud AR, Lin C. A review of the impact of preoperative chemoradiotherapy on outcome and postoperative complications in esophageal cancer patients. Am J Clin Oncol. 2015 Aug;38(4):415-21. doi: 10.1097/COC.0000000000000021.
- Background: PubMed 26254683Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.
- Background: PubMed 26411750Baker M, Halliday V, Williams RN, Bowrey DJ. A systematic review of the nutritional consequences of esophagectomy. Clin Nutr. 2016 Oct;35(5):987-94. doi: 10.1016/j.clnu.2015.08.010. Epub 2015 Sep 12.
- Background: PubMed 19847871Martin L, Lagergren P. Long-term weight change after oesophageal cancer surgery. Br J Surg. 2009 Nov;96(11):1308-14. doi: 10.1002/bjs.6723.
- Individual participant dataSharing planned: No
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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.
Roshaida Abdul Wahab, MD contact
Carel Le Roux, Pr, MD study chair
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oesophagectomy in people with Oesophageal Cancer, run by University College Dublin at 1 site in Ireland.
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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carel Le Roux, Pr, MD (+353864117842, carel.leroux@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the change in appetitive behaviour from baseline (before oesophagectomy) until 2 years following oesophagectomy using a progressive ratio task. (time frame: 0, 6, 12 and 24 months). The study lists 8 primary outcomes in all. 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 NCT05074914, which also lists 5 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 13 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.