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

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ClinicalTrials.gov Identifier: NCT02381249
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : November 7, 2018
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 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.


Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Stomach Neoplasms Weight Loss Malnutrition Pancreatic Neoplasms Duodenal Neoplasms Drug: Octreotide Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery
Study Start Date : March 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018


Arm Intervention/treatment
Experimental: Esophagectomy
Double-blind single dose octreotide-placebo crossover
Drug: Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Other Name: Sandostatin

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

Experimental: Gastrectomy
Double-blind single dose octreotide-placebo crossover
Drug: Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Other Name: Sandostatin

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

Active Comparator: Unoperated healthy control
Double-blind single dose octreotide-placebo crossover
Drug: Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Other Name: Sandostatin

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

Experimental: Pancreaticoduodenectomy
Double-blind single dose octreotide-placebo crossover
Drug: Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Other Name: Sandostatin

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




Primary Outcome Measures :
  1. Progressive ratio task breakpoint for a sweet-fat reward [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Number of rewards consumed [ Time Frame: 3 hours ]
  2. Subjective symptom score [ Time Frame: 3 hours ]

Other Outcome Measures:
  1. Sigstad score [ Time Frame: 3 hours ]
    Both categorical and continuous



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

Exclusion criteria:

  1. Pregnancy, breastfeeding
  2. Significant and persistent chemoradiotherapy and/or surgical complication
  3. Other previous upper gastrointestinal surgery
  4. Unwell or 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. Requiring adjuvant chemotherapy
  11. Contraindication to octreotide administration
  12. History of eating disorder

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): NCT02381249


Locations
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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
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Principal Investigator: John V Reynolds, MCh, FRCS Department of Surgery, St. James's Hospital

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Jessie A Elliott, Surgical Research Fellow, St. James's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT02381249     History of Changes
Other Study ID Numbers: CRFSJ 0057
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

Keywords provided by Dr Jessie A Elliott, St. James's Hospital, Ireland:
Esophagectomy
Gastrectomy
Octreotide
Somatostatin
Appetite
Hunger
Glucagon-Like Peptide 1
Peptide YY
Reinforcement
Reward
Psychological Phenomena and Processes
Gastrointestinal Agents
Nutritional Status
Pancreaticoduodenectomy
Whipple Procedure

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