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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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 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

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 octreotide-placebo crossover
Drug: Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Other Names:
  • Sandostatin
Drug: Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Experimental: Gastrectomy
Double-blind single dose octreotide-placebo crossover
Drug: Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Other Names:
  • Sandostatin
Drug: Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Active Comparator: Unoperated healthy control
Double-blind single dose octreotide-placebo crossover
Drug: Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Other Names:
  • Sandostatin
Drug: Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Experimental: Pancreaticoduodenectomy
Double-blind single dose octreotide-placebo crossover
Drug: Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Other Names:
  • Sandostatin
Drug: Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progressive ratio task breakpoint for a sweet-fat reward
Time Frame: 3 hours
3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of rewards consumed
Time Frame: 3 hours
3 hours
Subjective symptom score
Time Frame: 3 hours
3 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sigstad score
Time Frame: 3 hours
Both categorical and continuous
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

March 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimated)

March 6, 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 0057

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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