Clinical trial · Interventional
Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer
Food Intake and Gut Hormone Release in Patients in Cancer Remission Who Have Undergone Upper Gastrointestinal Surgery
- 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)
Improvements to treatment strategies for patients upper gastrointestinal cancers have produced an increasing population of people who remain free from disease recurrence in the long term. Weight loss and nutritional problems are common among patients who attain long-term remission and cure after surgery for upper gastrointestinal cancers. However, the mechanisms underlying these problems are not well understood. In this study the investigators aim to determine whether reduced food intake after upper gastrointestinal surgery is caused by early satiety related to exaggerated post-prandial gut hormone responses. This is a randomized, double-blind, placebo controlled, crossover study of the effect of 100μg octreotide SC on ad libitum food intake in patients free from complications or recurrence at least one year post-oesophagectomy, gastrectomy or pancreaticoduodenectomy. A comparator group of age, weight and gender matched subjects will be studied concurrently, and caloric intake and subjective symptom scores after administration of octreotide versus placebo among surgical and comparator subjects will be assessed.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malnutrition | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Octreotide | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Esophagectomy
- description
- Double blind single dose placebo-octreotide crossover
- interventionNames
- Drug: Octreotide
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Total gastrectomy
- description
- Double blind single dose placebo-octreotide crossover
- interventionNames
- Drug: Octreotide
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Control - no surgery
- description
- Double blind single dose placebo-octreotide crossover
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Surgical procedure: Two-stage, three-stage or transhiatal oesophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticodueodenectomy, or matched unoperated healthy controls 2. At least one year in remission post-resection (surgical groups) Exclusion Criteria: 1. Pregnancy, breastfeeding 2. Significant and persistent chemoradiotherapy and/or surgical complication 3. Other previous upper gastrointestinal surgery 4. Significant dysphagia or odynophagia, unable to eat 5. Other disease or medications which may affect satiety gut hormone responses 6. Active and significant psychiatric illness including substance misuse 7. Cognitive or communication issues or any factors affecting capacity to consent to participation 8. History of significant food allergy, certain dietary restrictions 9. Confirmed or suspected residual or recurrent disease after surgery, second primary malignancy 10. Other reconstruction (eg colonic or jejunal interposition) 11. Any contraindication to octreotide administration
References
Publications (11)
- BACKGROUNDle Roux CW, Welbourn R, Werling M, Osborne A, Kokkinos A, Laurenius A, Lonroth H, Fandriks L, Ghatei MA, Bloom SR, Olbers T. Gut hormones as mediators of appetite and weight loss after Roux-en-Y gastric bypass. Ann Surg. 2007 Nov;246(5):780-5. doi: 10.1097/SLA.0b013e3180caa3e3. PMID 17968169
- BACKGROUNDMartin L, Lagergren J, Lindblad M, Rouvelas I, Lagergren P. Malnutrition after oesophageal cancer surgery in Sweden. Br J Surg. 2007 Dec;94(12):1496-500. doi: 10.1002/bjs.5881. PMID 17668914
- BACKGROUNDHaverkort EB, Binnekade JM, de Haan RJ, Busch OR, van Berge Henegouwen MI, Gouma DJ. Suboptimal intake of nutrients after esophagectomy with gastric tube reconstruction. J Acad Nutr Diet. 2012 Jul;112(7):1080-7. doi: 10.1016/j.jand.2012.03.032. PMID 22889637
- BACKGROUNDDonohoe CL, McGillycuddy E, Reynolds JV. Long-term health-related quality of life for disease-free esophageal cancer patients. World J Surg. 2011 Aug;35(8):1853-60. doi: 10.1007/s00268-011-1123-6. PMID 21553202
- BACKGROUNDReynolds JV, McLaughlin R, Moore J, Rowley S, Ravi N, Byrne PJ. Prospective evaluation of quality of life in patients with localized oesophageal cancer treated by multimodality therapy or surgery alone. Br J Surg. 2006 Sep;93(9):1084-90. doi: 10.1002/bjs.5373. PMID 16779881
- BACKGROUNDMiholic J, Orskov C, Holst JJ, Kotzerke J, Pichlmayr R. Postprandial release of glucagon-like peptide-1, pancreatic glucagon, and insulin after esophageal resection. Digestion. 1993;54(2):73-8. doi: 10.1159/000201016. PMID 8319842
- BACKGROUNDMiras AD, le Roux CW. Mechanisms underlying weight loss after bariatric surgery. Nat Rev Gastroenterol Hepatol. 2013 Oct;10(10):575-84. doi: 10.1038/nrgastro.2013.119. Epub 2013 Jul 9. PMID 23835488