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Esophageal NeoplasmsNCT02385617

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

A study testing Octreotide in people with Esophageal Neoplasms and Stomach Neoplasms, run by St. James's Hospital, Ireland at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
What is being tested?
Octreotide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
2 sitesin 2 countries
Study dates
Jan 2014to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Ireland1 site

  • Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital

    Dublin, D8

Other trials in Ireland

Sweden1 site

  • Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg

    Gothenburg

Other trials in Sweden

About this study

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

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.

Being tested
Octreotide, Placebo
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
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Weight Loss, Malnutrition, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OctreotideDrug

    Also called Sandostatin

    Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating

  • PlaceboDrug

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

Study groups in NCT02385617
Study groupRoleWhat they receive
EsophagectomyExperimentalDouble blind single dose placebo-octreotide crossover
Receives: Drug: Octreotide; Drug: Placebo
Total gastrectomyExperimentalDouble blind single dose placebo-octreotide crossover
Receives: Drug: Octreotide; Drug: Placebo
Control - no surgeryActive comparatorDouble blind single dose placebo-octreotide crossover
Receives: Drug: Octreotide; Drug: Placebo
PancreaticoduodenectomyExperimentalDouble blind single dose placebo-octreotide crossover
Receives: Drug: Octreotide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ad libitum calorie intake

    Total kcals consumed

    Measured: 1 hour

Secondary outcomes (2)

  1. Post-prandial satiety gut hormone response

    GLP-1, PYY, OXM plasma concentrations

    Measured: 2 hours

  2. Subjective symptom scores

    Modified visual analogue scale scores

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385617
Sponsor's protocol ID
CRFSJ 0026
Other IDs
REC 2011/27/01
Status last verified
Nov 2023
First submitted
2 Mar 2015
Last updated
27 Nov 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17968169

  • 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.

    PubMed 17668914

  • 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.

    PubMed 22889637

  • 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.

    PubMed 21553202

  • 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.

    PubMed 16779881

  • 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.

    PubMed 8319842

  • 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.

    PubMed 23835488

  • 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.

    PubMed 21440118

  • 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.

    PubMed 16782437

  • 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.

    PubMed 22137988

  • 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.

    PubMed 26583672

Questions about this trial

What is this clinical trial studying?

A study testing Octreotide in people with Esophageal Neoplasms and Stomach Neoplasms, run by St. James's Hospital, Ireland at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ireland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ad libitum calorie intake (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02385617, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.

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