The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

Not Applicable

Completed

• Conditions: Pancreatic Neoplasms; Malnutrition; Weight Loss; Stomach Neoplasms; Esophageal Neoplasms; Duodenal Neoplasms
• Interventions: Drug: Octreotide; Drug: Placebo

• Registration Number: NCT02381249
• Lead Sponsor: St. James's Hospital, Ireland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Esophagectomy	Placebo	Double-blind single dose octreotide-placebo crossover
Gastrectomy	Placebo	Double-blind single dose octreotide-placebo crossover
Unoperated healthy control	Placebo	Double-blind single dose octreotide-placebo crossover
Pancreaticoduodenectomy	Placebo	Double-blind single dose octreotide-placebo crossover
Esophagectomy	Octreotide	Double-blind single dose octreotide-placebo crossover
Pancreaticoduodenectomy	Octreotide	Double-blind single dose octreotide-placebo crossover
Gastrectomy	Octreotide	Double-blind single dose octreotide-placebo crossover
Unoperated healthy control	Octreotide	Double-blind single dose octreotide-placebo crossover

Primary Outcome Measures

Name	Time	Method
Progressive ratio task breakpoint for a sweet-fat reward	3 hours

Secondary Outcome Measures

Name	Time	Method
Subjective symptom score	3 hours
Number of rewards consumed	3 hours

Trial Locations

Locations (2)

Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital; 🇮🇪 Dublin, Ireland

Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg; 🇸🇪 Gothenburg, Sweden