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

Not Applicable

Completed

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

• Registration Number: NCT02385617
• Lead Sponsor: St. James's Hospital, Ireland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Esophagectomy	Placebo	Double blind single dose placebo-octreotide crossover
Total gastrectomy	Placebo	Double blind single dose placebo-octreotide crossover
Control - no surgery	Placebo	Double blind single dose placebo-octreotide crossover
Pancreaticoduodenectomy	Placebo	Double blind single dose placebo-octreotide crossover
Pancreaticoduodenectomy	Octreotide	Double blind single dose placebo-octreotide crossover
Total gastrectomy	Octreotide	Double blind single dose placebo-octreotide crossover
Esophagectomy	Octreotide	Double blind single dose placebo-octreotide crossover
Control - no surgery	Octreotide	Double blind single dose placebo-octreotide crossover

Primary Outcome Measures

Name	Time	Method
Ad libitum calorie intake	1 hour	Total kcals consumed

Secondary Outcome Measures

Name	Time	Method
Subjective symptom scores	3 hours	Modified visual analogue scale scores
Post-prandial satiety gut hormone response	2 hours	GLP-1, PYY, OXM plasma concentrations

Trial Locations

Locations (2)

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

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