An interventional study of Octreotide and Placebo in Esophageal Neoplasms, Stomach Neoplasms and Weight Loss, sponsored by St. James's Hospital, Ireland. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by St. James's Hospital, Ireland · Not applicable, Interventional, and Basic science
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.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's enrollment of 20 is below the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →St. James's Hospital, Ireland is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Double blind single dose placebo-octreotide crossover
Drug: Octreotide · Drug: Placebo
Double blind single dose placebo-octreotide crossover
Drug: Octreotide · Drug: Placebo
Double blind single dose placebo-octreotide crossover
Drug: Octreotide · Drug: Placebo
Double blind single dose placebo-octreotide crossover
Drug: Octreotide · Drug: Placebo
Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Also known as: Sandostatin
0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Ad libitum calorie intake
Total kcals consumed
Time frame: 1 hour
Post-prandial satiety gut hormone response
GLP-1, PYY, OXM plasma concentrations
Time frame: 2 hours
Subjective symptom scores
Modified visual analogue scale scores
Time frame: 3 hours
The record gives a start of Jan 2014, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Octreotide
St. James's Hospital, Ireland