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Randomised clinical trial to evaluate postoperative quality of life and body weight loss with the use of EPA-enriched nutrient for resectable gastric cancer patients

Randomised clinical trial to evaluate postoperative quality of life and body weight loss with the use of EPA-enriched nutrient for resectable gastric cancer patients - Postoperative QOL and body weight loss with perioperative Prosure administration for gastric cancer patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010568
Enrollment
160
Registered
2013-04-23
Start date
2013-04-23
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

gastric cancer

Interventions

Oral supplimentation of 2 packs of Prosure per day for 7 days before surgery and 20 days after surgery. Oral supplimentation of 1 pack of Prosure and 1 can of Ensure Liquid per day for 7 days before s

Sponsors

Jichi Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. curative resection is possible by total gastrectomy or distal gastrectomy 2. not treated preoperative chemotherapy 3. age: 20-80 years 4. ECOG performance status: 0-1 5. sufficient organ functions 6. written informed consent

Exclusion criteria

Exclusion criteria: 1. reduced oral intake 2. Treated with icosapentate ethyl 3. supplements containing eicosapentaenoic acid 4. synchronous or metachronous cancer 5. lactate intolerance or allergic reaction to milk/soy 6. hemorrhagic tendency 7. uncontrolled diabetes mellitus 8. Systemic treatment with corticosteroids 9. unstable angina or cardiac infarction within 6 months 10. pulmonary disease under oxygenation 11. Woman with ongoing pregnancy or breast-feeding, or contemplating pregnancy

Design outcomes

Primary

MeasureTime frame
Body weight loss and QOL score at 1/2/3/6 months after surgery

Secondary

MeasureTime frame
postoperative functional disorder, lean body mass and skeletal muscle volume at 1/2/3/6 months after surgery, relative performance of Prosure, incidence of surgical morbidity.

Countries

Japan

Contacts

Public ContactKentaro Kurashina

Jichi Medical University Hospital Department of Surgery

kurashonan@jichi.ac.jp0285-58-7371

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026