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

• Conditions: Weight loss and malnutrition after curative surgery for upper gastrointestinal cancer; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-004150-17-SE
• Lead Sponsor: Västra Götalandsregionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-28
• Last Update Posted: 25 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified