RECRUITINGPhase 3INTERVENTIONAL

PROGAIN Trial in Gastric Cancer Surgery

The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written willing to sign a consent form to participate in this study. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Soonchunhyang University Cheonan Hospital

Cheonan, Chungcheongnam-do, South Korea