Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Food Intake and Gut Hormone Release in Patients in Cancer Remission Who Have Undergone Upper Gastrointestinal Surgery

Conditions
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Esophageal Neoplasms, Stomach Neoplasms, Weight Loss, Malnutrition

Intervention / Treatment
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* Drug: Octreotide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 At least one year in remission post-resection (surgical groups) Exclusion Criteria: Pregnancy, breastfeeding Significant and persistent chemoradiotherapy and/or surgical complication Other previous upper gastrointestinal surgery Significant dysphagia or odynophagia, unable to eat Other disease or medications which may affect satiety gut hormone responses Active and significant psychiatric illness including substance misuse Cognitive or communication issues or any factors affecting capacity to consent to participation History of significant food allergy, certain dietary restrictions Confirmed or suspected residual or recurrent disease after surgery, second primary malignancy Other reconstruction (eg colonic or jejunal interposition) Any contraindication to octreotide administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esophagectomy<br>Double blind single dose placebo-octreotide crossover | Drug: Octreotide<br>* Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating<br>* Other names: Sandostatin;Drug: Placebo<br>* 0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating<br>|
| Experimental: Total gastrectomy<br>Double blind single dose placebo-octreotide crossover | Drug: Octreotide<br>* Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating<br>* Other names: Sandostatin;Drug: Placebo<br>* 0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating<br>|
| Active Comparator: Control - no surgery<br>Double blind single dose placebo-octreotide crossover | Drug: Octreotide<br>* Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating<br>* Other names: Sandostatin;Drug: Placebo<br>* 0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating<br>|
| Experimental: Pancreaticoduodenectomy<br>Double blind single dose placebo-octreotide crossover | Drug: Octreotide<br>* Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating<br>* Other names: Sandostatin;Drug: Placebo<br>* 0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ad libitum calorie intake | Total kcals consumed | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial satiety gut hormone response | GLP-1, PYY, OXM plasma concentrations | 2 hours | 
| Subjective symptom scores | Modified visual analogue scale scores | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucagon-Like Peptide 1, Peptide YY, Ghrelin, Satiety Response, Appetite, Hunger, Somatostatin, Octreotide, Anastomosis, Roux-en-Y, Digestive System Surgical Procedures, Pharmacologic Actions, Physiological Effects of Drugs, Endocrine System Diseases, Enteroendocrine Cells, Gastrointestinal Agents