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

St. James's Hospital, Ireland

Status: Completed

Conditions: Weight Loss; Malnutrition; Stomach Neoplasms; Esophageal Neoplasms

Treatments: Drug: Octreotide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02385617

REC 2011/27/01 (Other Identifier)

CRFSJ 0026

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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
2. At least one year in remission post-resection (surgical groups)

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups

Esophagectomy

Experimental group

Description:

Double blind single dose placebo-octreotide crossover

Treatment:

Drug: Octreotide

Drug: Placebo

Total gastrectomy

Experimental group

Description:

Double blind single dose placebo-octreotide crossover

Treatment:

Drug: Octreotide

Drug: Placebo

Control - no surgery

Active Comparator group

Description:

Double blind single dose placebo-octreotide crossover

Treatment:

Drug: Octreotide

Drug: Placebo

Pancreaticoduodenectomy

Experimental group

Description:

Double blind single dose placebo-octreotide crossover

Treatment:

Drug: Octreotide

Drug: Placebo