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

November 23, 2023 updated by: Dr Jessie A Elliott, St. James's Hospital, Ireland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, D8
        • Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
  • Sweden
      • Gothenburg, Sweden
        • Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. James's Hospital, Ireland

Collaborators

Göteborg University
University College Dublin
University of Dublin, Trinity College

Investigators

  • Principal Investigator: John V Reynolds, MCh, FRCS, Department of Surgery, St. James's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimated)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFSJ 0026
  • REC 2011/27/01 (Other Identifier: St. James's Hospital Research Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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