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

Sponsor

St. James's Hospital, Ireland (Other)

Overall Status

Completed

CT.gov ID

NCT02385617

Collaborator

University College Dublin (Other), University of Dublin, Trinity College (Other), Göteborg University (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Neoplasms Stomach Neoplasms Weight Loss Malnutrition	Drug: Octreotide Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Esophagectomy Double blind single dose placebo-octreotide crossover	Drug: Octreotide Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating Other Names: Sandostatin Drug: Placebo 0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Experimental: Total gastrectomy Double blind single dose placebo-octreotide crossover	Drug: Octreotide Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating Other Names: Sandostatin Drug: Placebo 0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Active Comparator: Control - no surgery Double blind single dose placebo-octreotide crossover	Drug: Octreotide Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating Other Names: Sandostatin Drug: Placebo 0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Experimental: Pancreaticoduodenectomy Double blind single dose placebo-octreotide crossover	Drug: Octreotide Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating Other Names: Sandostatin Drug: Placebo 0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating

Outcome Measures

Primary Outcome Measures

Ad libitum calorie intake [1 hour]
Total kcals consumed

Secondary Outcome Measures

Post-prandial satiety gut hormone response [2 hours]
GLP-1, PYY, OXM plasma concentrations
Subjective symptom scores [3 hours]
Modified visual analogue scale scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital	Dublin		Ireland	D8
2	Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg	Gothenburg		Sweden