PROGAIN Trial in Gastric Cancer Surgery
NCT07488611 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2026-05-19
Summary
This randomized study will evaluate whether protein-enriched parenteral nutrition improves early postoperative recovery in patients undergoing gastrectomy for gastric cancer. Participants will be assigned to receive either protein-enriched parenteral nutrition or standard parenteral nutrition during the perioperative period. The primary outcome is nitrogen balance on postoperative day 5. Secondary outcomes include postoperative complications, recovery of oral intake, and short-term changes in nutritional status and body composition.
Conditions
- Stomach (Gastric) Cancer
Interventions
- DRUG
-
Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)
A novel, high-amino acid peripheral parenteral nutrition formulation (Winuf A+ injection; JW Pharmaceutical) designed to provide optimal protein delivery with lower glucose load. Administered intravenously.
- DRUG
-
Standard peripheral parenteral nutrition (Winuf injection)
A conventional, standard 3-chamber peripheral parenteral nutrition formulation (Winuf injection; JW Pharmaceutical). Administered intravenously.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Soonchunhyang University Hospital
lead OTHER
Principal Investigators
-
Geum Jong Song, MD, PhD · Soonchunhyang University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-13
- Primary Completion
- 2027-02-28
- Completion
- 2028-03-31
Countries
- South Korea
Study Locations
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