Clinical trial · Interventional
Unintentional Weight Loss After Oesophagectomy
Mechanisms and Treatment of Unintentional Weight Loss After Oesophagectomy With Curative Intent
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: 1. Oesophagectomy induces changes in the small intestine barrier (gut mucosa) and changes in hormonal signals after food consumption. 2. 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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oesophageal Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oesophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adenocarcinoma of the oesophagus
- description
- curative oesophagectomy
- interventionNames
- Procedure: oesophagectomy
- type
- NO_INTERVENTION
- label
- Barrett's oesophagus
- description
- Weight stable patient under survelliance with Barrett's oespophagus
Primary outcomes (8)
- measure
- Measurement of the change in appetitive behaviour from baseline (before oesophagectomy) until 2 years following oesophagectomy using a progressive ratio task.
- timeFrame
- 0, 6, 12 and 24 months
- description
- measured using Progressive ratio task
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
A. 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
B. Barrett's oesophagus group:
-Barrett's oesophagus group who are under surveillance from INCEUGIN
Exclusion Criteria:
* 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
* 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 insulinReferences
Publications (5)
- BACKGROUNDStahl 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. PMID 24078662
- BACKGROUNDWilke 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. PMID 24351783
- BACKGROUNDShapiro 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. PMID 26254683
- BACKGROUNDBaker 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. PMID 26411750
- BACKGROUNDMartin 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. PMID 19847871