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

NCT02385617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-27

No results posted yet for this study

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.

Conditions

  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Weight Loss
  • Malnutrition

Interventions

DRUG

Octreotide

Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating

DRUG

Placebo

0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating

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
2014-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Ireland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02385617 on ClinicalTrials.gov