PROGAIN Trial in Gastric Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Protein-enriched peripheral parenteral nutrition (Winuf A+ injection), Standard peripheral parenteral nutrition (Winuf injection).
- Who it may be relevant to
- Registry conditions: Stomach (Gastric) Cancer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery
Overview
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.
Detailed 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.
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.
Primary outcome measures
- Nitrogen Balance [Time frame: Postoperative Day 5 (POD 5)]
Secondary outcome measures (8)
- Skeletal Muscle Index (Sarcopenia Assessment) [Time frame: Baseline (preoperative), and 6 months postoperativel]
- Nutritional Status Assessed by GLIM Criteria [Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively]
- Complications [Time frame: Up to 30 days postoperatively]
- Glycemic Control [Time frame: Postoperative Day 1 to Day 5]
- Functional Recovery [Time frame: Up to hospital discharge (expected average up to 7-10 days)]
- Prognostic Nutritional Index (PNI) [Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively]
- C-Reactive Protein to Albumin Ratio (CAR) [Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively]
- Modified Glasgow Prognostic Score (mGPS) [Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Soonchunhyang University Cheonan Hospital — Cheonan
Identifiers
NCT: NCT07488611 · 2025-11-024