PROGAIN Trial in Gastric Cancer Surgery

Soon Chun Hyang University

Status and phase: Enrolling; Phase 3

Conditions: Stomach (Gastric) Cancer

Treatments: Drug: Standard peripheral parenteral nutrition (Winuf injection); Drug: Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07488611

2025-11-024

Details and patient eligibility

About

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.

Full description

Gastrectomy for gastric cancer induces a significant postoperative catabolic state, making adequate protein delivery crucial for optimal tissue healing and recovery. In the modern era of Enhanced Recovery After Surgery (ERAS) protocols, the routine use of central venous catheters for total parenteral nutrition (CPN) is heavily discouraged due to its invasiveness, infection risks, and hindrance to early mobilization. Consequently, Supplemental Parenteral Nutrition (SPN) via a peripheral route has emerged as the preferred strategy to bridge the nutritional gap when early oral intake is insufficient.

However, traditional standard peripheral parenteral nutrition (PPN) is inherently limited by osmolarity constraints to prevent peripheral phlebitis. This physical restriction often results in a critically inadequate supply of amino acids, failing to meet the heightened protein demands required to reverse acute postoperative catabolism and prevent rapid muscle depletion.

Recently, novel protein-enriched peripheral parenteral formulations have been developed to overcome this exact limitation, allowing for a higher, optimal amino acid load to be delivered safely via peripheral veins. The PROGAIN trial aims to evaluate the clinical impact of these advanced formulations. The investigators hypothesize that utilizing protein-enriched PPN, compared to standard PPN, will effectively blunt the catabolic response, significantly improve postoperative nitrogen balance, and facilitate earlier functional recovery in gastric cancer patients without compromising the principles of the ERAS pathway.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Protein-enriched PPN

Experimental group

Description:

Patients assigned to this arm will receive a 4th-generation, protein-enriched peripheral parenteral nutrition (PPN). The intervention will be administered for a total of 6 days, starting from preoperative day 1 (POD -1) to postoperative day 5 (POD 5), excluding the day of surgery (POD 0). The daily infusion volume is dynamically individualized; it is titrated based on the patient's target nutritional requirements and their actual daily oral intake.

Treatment:

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

Standard PPN

Active Comparator group

Description:

Patients assigned to this arm will receive a 3rd-generation, standard peripheral parenteral nutrition (PPN). The administration schedule is identical to the experimental arm (a total of 6 days, excluding POD 0). Similarly, the daily infusion volume is individualized and titrated according to the patient's actual oral caloric intake.

Treatment:

Drug: Standard peripheral parenteral nutrition (Winuf injection)