Back to resultsFood Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer
Primary Purpose
Esophageal Neoplasms, Stomach Neoplasms, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Octreotide
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Esophageal Neoplasms focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
- Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Experimental
Arm Label
Esophagectomy
Total gastrectomy
Control - no surgery
Pancreaticoduodenectomy
Arm Description
Double blind single dose placebo-octreotide crossover
Double blind single dose placebo-octreotide crossover
Double blind single dose placebo-octreotide crossover
Double blind single dose placebo-octreotide crossover
Outcomes
Primary Outcome Measures
Ad libitum calorie intake
Total kcals consumed
Secondary Outcome Measures
Post-prandial satiety gut hormone response
GLP-1, PYY, OXM plasma concentrations
Subjective symptom scores
Modified visual analogue scale scores
Full Information
NCT ID
NCT02385617
First Posted
March 2, 2015
Last Updated
November 6, 2018
Sponsor
St. James's Hospital, Ireland
Collaborators
University College Dublin, University of Dublin, Trinity College, Göteborg University
1. Study Identification
Unique Protocol Identification Number
NCT02385617
Brief Title
Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer
Official Title
Food Intake and Gut Hormone Release in Patients in Cancer Remission Who Have Undergone Upper Gastrointestinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. James's Hospital, Ireland
Collaborators
University College Dublin, University of Dublin, Trinity College, Göteborg University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Stomach Neoplasms, Weight Loss, Malnutrition
Keywords
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
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esophagectomy
Arm Type
Experimental
Arm Description
Double blind single dose placebo-octreotide crossover
Arm Title
Total gastrectomy
Arm Type
Experimental
Arm Description
Double blind single dose placebo-octreotide crossover
Arm Title
Control - no surgery
Arm Type
Active Comparator
Arm Description
Double blind single dose placebo-octreotide crossover
Arm Title
Pancreaticoduodenectomy
Arm Type
Experimental
Arm Description
Double blind single dose placebo-octreotide crossover
Intervention Type
Drug
Intervention Name(s)
Octreotide
Other Intervention Name(s)
Sandostatin
Intervention Description
Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Primary Outcome Measure Information:
Title
Ad libitum calorie intake
Description
Total kcals consumed
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Post-prandial satiety gut hormone response
Description
GLP-1, PYY, OXM plasma concentrations
Time Frame
2 hours
Title
Subjective symptom scores
Description
Modified visual analogue scale scores
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John V Reynolds, MCh, FRCS
Organizational Affiliation
Department of Surgery, St. James's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
City
Dublin
ZIP/Postal Code
D8
Country
Ireland
Facility Name
Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
17968169
Citation
le Roux CW, Welbourn R, Werling M, Osborne A, Kokkinos A, Laurenius A, Lonroth H, Fandriks L, Ghatei MA, Bloom SR, Olbers T. Gut hormones as mediators of appetite and weight loss after Roux-en-Y gastric bypass. Ann Surg. 2007 Nov;246(5):780-5. doi: 10.1097/SLA.0b013e3180caa3e3.
Results Reference
background
PubMed Identifier
17668914
Citation
Martin L, Lagergren J, Lindblad M, Rouvelas I, Lagergren P. Malnutrition after oesophageal cancer surgery in Sweden. Br J Surg. 2007 Dec;94(12):1496-500. doi: 10.1002/bjs.5881.
Results Reference
background
PubMed Identifier
22889637
Citation
Haverkort EB, Binnekade JM, de Haan RJ, Busch OR, van Berge Henegouwen MI, Gouma DJ. Suboptimal intake of nutrients after esophagectomy with gastric tube reconstruction. J Acad Nutr Diet. 2012 Jul;112(7):1080-7. doi: 10.1016/j.jand.2012.03.032.
Results Reference
background
PubMed Identifier
21553202
Citation
Donohoe CL, McGillycuddy E, Reynolds JV. Long-term health-related quality of life for disease-free esophageal cancer patients. World J Surg. 2011 Aug;35(8):1853-60. doi: 10.1007/s00268-011-1123-6.
Results Reference
background
PubMed Identifier
16779881
Citation
Reynolds JV, McLaughlin R, Moore J, Rowley S, Ravi N, Byrne PJ. Prospective evaluation of quality of life in patients with localized oesophageal cancer treated by multimodality therapy or surgery alone. Br J Surg. 2006 Sep;93(9):1084-90. doi: 10.1002/bjs.5373.
Results Reference
background
PubMed Identifier
8319842
Citation
Miholic J, Orskov C, Holst JJ, Kotzerke J, Pichlmayr R. Postprandial release of glucagon-like peptide-1, pancreatic glucagon, and insulin after esophageal resection. Digestion. 1993;54(2):73-8. doi: 10.1159/000201016.
Results Reference
background
PubMed Identifier
23835488
Citation
Miras AD, le Roux CW. Mechanisms underlying weight loss after bariatric surgery. Nat Rev Gastroenterol Hepatol. 2013 Oct;10(10):575-84. doi: 10.1038/nrgastro.2013.119. Epub 2013 Jul 9.
Results Reference
background
PubMed Identifier
21440118
Citation
Koizumi M, Hosoya Y, Dezaki K, Yada T, Hosoda H, Kangawa K, Nagai H, Lefor AT, Sata N, Yasuda Y. Postoperative weight loss does not resolve after esophagectomy despite normal serum ghrelin levels. Ann Thorac Surg. 2011 Apr;91(4):1032-7. doi: 10.1016/j.athoracsur.2010.11.072.
Results Reference
background
PubMed Identifier
16782437
Citation
Doki Y, Takachi K, Ishikawa O, Miyashiro I, Sasaki Y, Ohigashi H, Nakajima H, Hosoda H, Kangawa K, Sasakuma F, Motoori M, Imaoka S. Ghrelin reduction after esophageal substitution and its correlation to postoperative body weight loss in esophageal cancer patients. Surgery. 2006 Jun;139(6):797-805. doi: 10.1016/j.surg.2005.11.015.
Results Reference
background
PubMed Identifier
22137988
Citation
Miyazaki T, Tanaka N, Hirai H, Yokobori T, Sano A, Sakai M, Inose T, Sohda M, Nakajima M, Fukuchi M, Kato H, Kuwano H. Ghrelin level and body weight loss after esophagectomy for esophageal cancer. J Surg Res. 2012 Jul;176(1):74-8. doi: 10.1016/j.jss.2011.09.016. Epub 2011 Oct 3.
Results Reference
background
PubMed Identifier
26583672
Citation
Elliott JA, Jackson S, King S, McHugh R, Docherty NG, Reynolds JV, le Roux CW. Gut Hormone Suppression Increases Food Intake After Esophagectomy With Gastric Conduit Reconstruction. Ann Surg. 2015 Nov;262(5):824-29; discussion 829-30. doi: 10.1097/SLA.0000000000001465.
Results Reference
result
Links:
URL
http://www.sjhcrf.ie/
Description
Wellcome Trust-HRB Clinical Research Facility
URL
https://medicine.tcd.ie/surgery/
Description
Department of Surgery, Trinity College Dublin
URL
http://www.ucd.ie/conway/
Description
Conway Institute of Biomolecular and Biomedical Research
URL
http://www.stjames.ie/
Description
St James's Hospital, Dublin
URL
http://www.gu.se/english
Description
University of Gothenburg
Learn more about this trial
Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer
We'll reach out to this number within 24 hrs