Esophageal Neoplasms, Malnutrition, Stomach Neoplasms, Weight Loss
Conditions
Keywords
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
Brief summary
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.
Interventions
DRUGOctreotide
Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
DRUGPlacebo
0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Sponsors
University College Dublin
University of Dublin, Trinity College
Göteborg University
St. James's Hospital, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ad libitum calorie intake | 1 hour | Total kcals consumed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-prandial satiety gut hormone response | 2 hours | GLP-1, PYY, OXM plasma concentrations |
| Subjective symptom scores | 3 hours | Modified visual analogue scale scores |
Countries
Ireland, Sweden
Outcome results
None listed