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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385617
• Other study ID #: CRFSJ 0026
• Secondary ID: REC 2011/27/01
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2023
• Source: St. James's Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Malnutrition
• Neoplasms
• Stomach Neoplasms
• Weight Loss

Intervention

Drug:
• 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

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
St. James's Hospital, Ireland	Göteborg University, University College Dublin, University of Dublin, Trinity College

Countries where clinical trial is conducted

Ireland,  Sweden, 

References & Publications (11)

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. — View 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. — View 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.000 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ad libitum calorie intake	Total kcals consumed	1 hour
Secondary	Post-prandial satiety gut hormone response	GLP-1, PYY, OXM plasma concentrations	2 hours
Secondary	Subjective symptom scores	Modified visual analogue scale scores	3 hours

External Links

•   Conway Institute of Biomolecular and Biomedical Research
•   Department of Surgery, Trinity College Dublin
•   St James's Hospital, Dublin
•   University of Gothenburg
•   Wellcome Trust-HRB Clinical Research Facility