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

NCT02381249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-27

No results posted yet for this study

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.

Conditions

  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Weight Loss
  • Malnutrition
  • Pancreatic Neoplasms
  • Duodenal Neoplasms

Interventions

DRUG

Octreotide

Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

DRUG

Placebo

Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen

Sponsors & Collaborators

  • University College Dublin

    collaborator OTHER
  • University of Dublin, Trinity College

    collaborator OTHER
  • Göteborg University

    collaborator OTHER
  • St. James's Hospital, Ireland

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Ireland
  • Sweden

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02381249 on ClinicalTrials.gov