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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004150-17-SE

Enrollment

Registered

2015-10-28

Start date

2015-12-11

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight loss and malnutrition after curative surgery for upper gastrointestinal cancer

Interventions

Trade Name: Sandostantin Product Name: Sandostatin Product Code: 19890609000031 Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Sub

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Surgical procedure: Oesophagectomy, total gastrectomy or pancreatic duodenectomy (Whipple procedure) or matched unoperated healthy controls 2. At least one year in remission post-resection (surgical groups) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Pregnancy, breastfeeding 2. Significant and persistent chemoradiotherapy and/or surgical complication 3. Other previous upper gastrointestinal surgery 4. Unwell or 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. Requiring adjuvant chemotherapy 11. Contraindication to octreotide administration 12. History of eating disorder

Design outcomes

Primary

Measure	Time frame
Main Objective: Improvements to treatment strategies for patients with oesophageal, gastric and pancreatic cancer 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 we aim to determine whether reduced food intake after upper gastrointestinal surgery is caused by early satiety related to exaggerated post-prandial gut hormone responses.;Secondary Objective: Not applicable.;Primary end point(s): Ad libitum calorie intake Progressive ratio task breakpoint for a sweet-fat reward;Timepoint(s) of evaluation of this end point: September 2017	—

Measure

Time frame

Main Objective: Improvements to treatment strategies for patients with oesophageal, gastric and pancreatic cancer 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 we aim to determine whether reduced food intake after upper gastrointestinal surgery is caused by early satiety related to exaggerated post-prandial gut hormone responses.;Secondary Objective: Not applicable.;Primary end point(s): Ad libitum calorie intake Progressive ratio task breakpoint for a sweet-fat reward;Timepoint(s) of evaluation of this end point: September 2017

—

Secondary

Measure	Time frame
Secondary end point(s): Post-prandial satiety gut hormone response Number of rewards consumed Subjective symptom score;Timepoint(s) of evaluation of this end point: September 2017	—

Countries

Sweden

Contacts

Public ContactSjuksköterskeexpedition

Gastroenterologlab, "Gast.lab." SU/Sahlrenska

gastlab.su@vgregion.se0046313428404

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026