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NCT Number: NCT02385617

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

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.

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Key information

Conditions

Esophageal Neoplasms Body Weight Body Weight Changes Digestive System Diseases Digestive System Neoplasms Endocrine System Diseases Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases Stomach Neoplasms Weight Loss

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital, Dublin, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • At least one year in remission post-resection (surgical groups)

Exclusion criteria

  • Pregnancy, breastfeeding
  • Significant and persistent chemoradiotherapy and/or surgical complication
  • Other previous upper gastrointestinal surgery
  • Significant dysphagia or odynophagia, unable to eat
  • Other disease or medications which may affect satiety gut hormone responses
  • Active and significant psychiatric illness including substance misuse
  • Cognitive or communication issues or any factors affecting capacity to consent to participation
  • History of significant food allergy, certain dietary restrictions
  • Confirmed or suspected residual or recurrent disease after surgery, second primary malignancy
  • Other reconstruction (eg colonic or jejunal interposition)
  • Any contraindication to octreotide administration

Treatment and study plan

Octreotide

Drug

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

Other names: Sandostatin

Placebo

Drug

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

Primary outcomes

  1. Ad libitum calorie intake

    Time frame: 1 hour

    Total kcals consumed

Secondary outcomes

  1. Post-prandial satiety gut hormone response

    Time frame: 2 hours

    GLP-1, PYY, OXM plasma concentrations

  2. Subjective symptom scores

    Time frame: 3 hours

    Modified visual analogue scale scores

Sponsors and collaborators

Lead sponsor

St. James's Hospital, Ireland

Other

Collaborators

  • Göteborg University
  • University College Dublin
  • University of Dublin, Trinity College

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2015
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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