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NCT Number: NCT02381249

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

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.

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Key information

Conditions

Esophageal Neoplasms Body Weight Body Weight Changes Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Duodenal Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Neoplasms 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

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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 esophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticoduodenectomy, or matched healthy unoperated control subjects
  • Disease-free at least one year post-resection

Exclusion criteria

  • Pregnancy, breastfeeding
  • Significant and persistent chemoradiotherapy and/or surgical complication
  • Other previous upper gastrointestinal surgery
  • Unwell or 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
  • Requiring adjuvant chemotherapy
  • Contraindication to octreotide administration
  • History of eating disorder

Treatment and study plan

Octreotide

Drug

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

Other names: Sandostatin

Placebo

Drug

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

Primary outcomes

  1. Progressive ratio task breakpoint for a sweet-fat reward

    Time frame: 3 hours

Secondary outcomes

  1. Number of rewards consumed

    Time frame: 3 hours

  2. Subjective symptom score

    Time frame: 3 hours

Other outcomes

  1. Sigstad score

    Time frame: 3 hours

    Both categorical and continuous

Sponsors and collaborators

Lead sponsor

St. James's Hospital, Ireland

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 6, 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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