Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer
NCT ID: NCT02385617
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Esophagectomy
Double blind single dose placebo-octreotide crossover
Octreotide
Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Placebo
0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Total gastrectomy
Double blind single dose placebo-octreotide crossover
Octreotide
Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Placebo
0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Control - no surgery
Double blind single dose placebo-octreotide crossover
Octreotide
Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Placebo
0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Pancreaticoduodenectomy
Double blind single dose placebo-octreotide crossover
Octreotide
Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Placebo
0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Interventions
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Octreotide
Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Placebo
0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one year in remission post-resection (surgical groups)
Exclusion Criteria
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
18 Years
100 Years
ALL
Yes
Sponsors
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University College Dublin
OTHER
University of Dublin, Trinity College
OTHER
Göteborg University
OTHER
St. James's Hospital, Ireland
OTHER
Responsible Party
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Dr Jessie A Elliott
Surgical Research Fellow
Principal Investigators
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John V Reynolds, MCh, FRCS
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, St. James's Hospital
Locations
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Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Dublin, , Ireland
Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg
Gothenburg, , Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Wellcome Trust-HRB Clinical Research Facility
Conway Institute of Biomolecular and Biomedical Research
St James's Hospital, Dublin
University of Gothenburg
Other Identifiers
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REC 2011/27/01
Identifier Type: OTHER
Identifier Source: secondary_id
CRFSJ 0026
Identifier Type: -
Identifier Source: org_study_id