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Trial record 2 of 4 for:    17968169 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02385617
Recruitment Status : Unknown
Verified February 2016 by Dr Jessie A Elliott, St. James's Hospital, Ireland.
Recruitment status was:  Enrolling by invitation
First Posted : March 11, 2015
Last Update Posted : February 10, 2016
Sponsor:
Collaborators:
University College Dublin
University of Dublin, Trinity College
Göteborg University
Information provided by (Responsible Party):
Dr Jessie A Elliott, St. James's Hospital, Ireland

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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 Name: 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 Name: 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 Name: 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 Name: Sandostatin

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




Primary Outcome Measures :
  1. Ad libitum calorie intake [ Time Frame: 1 hour ]
    Total kcals consumed


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385617


Locations
Ireland
Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Dublin, Ireland, D8
Sweden
Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg
Gothenburg, Sweden
Sponsors and Collaborators
St. James's Hospital, Ireland
University College Dublin
University of Dublin, Trinity College
Göteborg University
Investigators
Principal Investigator: John V Reynolds, MCh, FRCS Department of Surgery, St. James's Hospital

Additional Information:
Publications of Results:
Other Publications:

Responsible Party: Dr Jessie A Elliott, Surgical Research Fellow, St. James's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT02385617     History of Changes
Other Study ID Numbers: CRFSJ 0026
REC 2011/27/01 ( Other Identifier: St. James's Hospital Research Ethics Committee )
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016

Keywords provided by Dr Jessie A Elliott, St. James's Hospital, Ireland:
Glucagon-Like Peptide 1
Peptide YY
Ghrelin
Satiety Response
Appetite
Hunger
Somatostatin
Octreotide
Anastomosis, Roux-en-Y
Digestive System Surgical Procedures
Pharmacologic Actions
Physiological Effects of Drugs
Endocrine System Diseases
Enteroendocrine Cells
Gastrointestinal Agents

Additional relevant MeSH terms:
Neoplasms
Weight Loss
Malnutrition
Stomach Neoplasms
Esophageal Neoplasms
Body Weight Changes
Body Weight
Signs and Symptoms
Nutrition Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Hormones
Octreotide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents