CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Octreotide +1 moredrug
Likely dose
Octreotide 100mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02385617
NCT02385617N/ACompleted

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

St. James's Hospital, Ireland·interventional·Posted Mar 11, 2015·Updated Nov 27, 2023

In Brief

A clinical study evaluating Octreotide and Placebo for Esophageal Neoplasms and 3 related conditions. Completed, enrolled 20 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland, Sweden

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 11, 2015
Enrollment StartJan 1, 2014
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.3 years ago

Interventions

Octreotidedrug

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

Placebodrug

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