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Esophageal NeoplasmsNCT02381249

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

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 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. 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
40 participants
Where
2 sitesin 2 countries
Study dates
Mar 2015to Mar 2018
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 esophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticoduodenectomy, or matched healthy unoperated control subjects
  • Disease-free at least one year post-resection

Who cannot join

  • Pregnancy, breastfeeding
  • Significant and persistent chemoradiotherapy and/or surgical complication
  • Other previous upper gastrointestinal surgery
  • Unwell or unable to eat
  • Other disease or medications which may affect satiety gut hormone responses
  • Active and significant psychiatric illness including substance misuse
Show all 12Show 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
  • Requiring adjuvant chemotherapy
  • Contraindication to octreotide administration
  • History of eating disorder

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

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.

Read more

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.

Being tested
Octreotide, Placebo
Keywords
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
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Weight Loss, Malnutrition, Pancreatic Neoplasms, Duodenal Neoplasms

What participants receive

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

  • OctreotideDrug

    Also called Sandostatin

    Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

  • PlaceboDrug

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

Study groups in NCT02381249
Study groupRoleWhat they receive
EsophagectomyExperimentalDouble-blind single dose octreotide-placebo crossover
Receives: Drug: Octreotide; Drug: Placebo
GastrectomyExperimentalDouble-blind single dose octreotide-placebo crossover
Receives: Drug: Octreotide; Drug: Placebo
Unoperated healthy controlActive comparatorDouble-blind single dose octreotide-placebo crossover
Receives: Drug: Octreotide; Drug: Placebo
PancreaticoduodenectomyExperimentalDouble-blind single dose octreotide-placebo crossover
Receives: Drug: Octreotide; Drug: Placebo

What is being measured

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

  1. Progressive ratio task breakpoint for a sweet-fat reward

    Measured: 3 hours

Secondary outcomes (2)

  1. Number of rewards consumed

    Measured: 3 hours

  2. Subjective symptom score

    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 posted6 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2018
  4. Study completionMar 2018

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02381249
Sponsor's protocol ID
CRFSJ 0057
Status last verified
Nov 2023
First submitted
2 Mar 2015
Last updated
27 Nov 2023
Results posted
No
Data monitoring committee
No

Publications

  • Miras AD, Jackson RN, Jackson SN, Goldstone AP, Olbers T, Hackenberg T, Spector AC, le Roux CW. Gastric bypass surgery for obesity decreases the reward value of a sweet-fat stimulus as assessed in a progressive ratio task. Am J Clin Nutr. 2012 Sep;96(3):467-73. doi: 10.3945/ajcn.112.036921. Epub 2012 Jul 25.

    PubMed 22836034

  • HODOS W. Progressive ratio as a measure of reward strength. Science. 1961 Sep 29;134(3483):943-4. doi: 10.1126/science.134.3483.943.

    PubMed 13714876

  • 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

  • Haverkort EB, Binnekade JM, Busch OR, van Berge Henegouwen MI, de Haan RJ, Gouma DJ. Presence and persistence of nutrition-related symptoms during the first year following esophagectomy with gastric tube reconstruction in clinically disease-free patients. World J Surg. 2010 Dec;34(12):2844-52. doi: 10.1007/s00268-010-0786-8.

    PubMed 20842361

  • 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

  • le Roux CW, Aylwin SJ, Batterham RL, Borg CM, Coyle F, Prasad V, Shurey S, Ghatei MA, Patel AG, Bloom SR. Gut hormone profiles following bariatric surgery favor an anorectic state, facilitate weight loss, and improve metabolic parameters. Ann Surg. 2006 Jan;243(1):108-14. doi: 10.1097/01.sla.0000183349.16877.84.

    PubMed 16371744

  • Elliott JA, Docherty NG, Haag J, Eckhardt HG, Ravi N, Reynolds JV, le Roux CW. Attenuation of satiety gut hormones increases appetitive behavior after curative esophagectomy for esophageal cancer. Am J Clin Nutr. 2019 Feb 1;109(2):335-344. doi: 10.1093/ajcn/nqy324.

    PubMed 30722001

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 12 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?

Progressive ratio task breakpoint for a sweet-fat reward (time frame: 3 hours). 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 NCT02381249, which also lists 7 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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