PROGAIN Trial in Gastric Cancer Surgery

NCT07488611 · tracked via the Priya Life Science South Korea tracker

Sponsor

Soonchunhyang University Hospital

Phase

Phase 3

Started

2026-02-13

Last updated

2026-05-19

Condition(s) studied

Stomach (Gastric) Cancer

Investigational drug(s) / intervention(s)

Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)Standard peripheral parenteral nutrition (Winuf injection)

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.

Standard peripheral parenteral nutrition (Winuf injection): A conventional, standard 3-chamber peripheral parenteral nutrition formulation (Winuf injection; JW Pharmaceutical). Administered intravenously.

Study 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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study. Exclusion Criteria: * Patients with uncontrolled severe systemic diseases (e.g., decompensated diabetes, cerebrovascular event within the last 6 months, sepsis, heart failure). * Patients who have received intravenous parenteral nutrition within 7 days prior to randomization. * Patients with severe metabolic abnormalities confirmed by preoperative laboratory tests, including but not limited to: * Triglyceride \> 400 mg/dL * AST or ALT \> 3 x Upper Limit of Normal (ULN) * Total Bilirubin \> 3 x ULN * Serum Creatinine \> 2 x ULN * HbA1c \> 9.0% * Potassium \< 3.0 mEq/L or \> 6.0 mEq/L * Calcium \> 12.5 mg/dL * Sodium \> 155 mmol/L * Magnesium \> 3.0 mg/dL * Patients deemed inappropriate for participation in this clinical trial by the investigator.

Primary outcome measure(s)

Nitrogen Balance — Postoperative Day 5 (POD 5)
Change in nitrogen balance, assessed by measuring 24-hour urinary urea nitrogen excretion and calculating total daily protein intake (from both oral diet and parenteral nutrition)

Trial sites (1)

Facility	City	Region	Status
Soonchunhyang University Cheonan Hospital	Cheonan	Chungcheongnam-do	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07488611 on ClinicalTrials.gov ↗ ← All trials in South Korea