Duodenal Neoplasms, Esophageal Neoplasms, Malnutrition, Pancreatic Neoplasms, Stomach Neoplasms, Weight Loss
Conditions
Keywords
Esophagectomy, Gastrectomy, Octreotide, Somatostatin, Appetite, Hunger, Glucagon-Like Peptide 1, Peptide YY, Reinforcement, Reward, Psychological Phenomena and Processes, Gastrointestinal Agents, Nutritional Status, Pancreaticoduodenectomy, Whipple Procedure
Brief summary
Improvements to treatment strategies for patients with cancers of the upper gastrointestinal tract have produced a large population of people who remain free from cancer recurrence in the long term following treatment. Surgery is the cornerstone of treatment for patients with these cancers, but while surgical removal of the tumour may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited. Our research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone this type of surgery. These chemical messengers play a role in controlling appetite and interest in food, and increased levels after surgery may reduce interest in eating. Understanding the role of gut hormones in the control of appetite may allow us to use certain medications to block gut hormones and hence increase appetite, allowing patients to eat more and regain weight, preventing nutritional problems after surgery. In this study, the investigators aim to determine whether exaggerated gut hormone secretion causes reduced appetite and interest in food after surgery. The information gained from this study may help us to develop treatments for patients with weight loss and nutritional problems after surgery.
Interventions
DRUGOctreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
DRUGPlacebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
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 esophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticoduodenectomy, or matched healthy unoperated control subjects 2. Disease-free at least one year post-resection
Exclusion criteria
1. Pregnancy, breastfeeding 2. Significant and persistent chemoradiotherapy and/or surgical complication 3. Other previous upper gastrointestinal surgery 4. Unwell or 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. Requiring adjuvant chemotherapy 11. Contraindication to octreotide administration 12. History of eating disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive ratio task breakpoint for a sweet-fat reward | 3 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of rewards consumed | 3 hours |
| Subjective symptom score | 3 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sigstad score | 3 hours | Both categorical and continuous |
Countries
Ireland, Sweden
Outcome results
None listed