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PROGAIN Trial in Gastric Cancer Surgery

ConditionStomach (Gastric) Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorSoonchunhyang University Hospital

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study.

Disqualifiers

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.

Triglyceride > 400 mg/dL

AST or ALT > 3 x Upper Limit of Normal (ULN)

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    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)

    Drug

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Protein-enriched PPNExperimental treatment 1 intervention
Group B: Standard PPNActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Nitrogen Balance

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)

Time frame
Postoperative Day 5 (POD 5)

Secondary outcomes

1

Skeletal Muscle Index (Sarcopenia Assessment)

Quantitative changes in skeletal muscle mass evaluated using the Skeletal Muscle Index (SMI). SMI is a continuous physiological measurement derived from cross-sectional imaging (such as abdominal computed tomography) and/or bioelectrical impedance analysis (BIA). Because it is a continuous physiological variable, there are no predefined minimum or maximum values on a scale. Higher SMI values indicate greater skeletal muscle mass, representing a better clinical outcome (prevention of muscle depletion).

Time frame
Baseline (preoperative), and 6 months postoperativel
2

Nutritional Status Assessed by GLIM Criteria

Change in nutritional status evaluated using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Participants will be categorized into normal nutritional status, moderate malnutrition, or severe malnutrition. This is a categorical assessment, not a numerical scale with minimum or maximum values. The "normal nutritional status" category represents the best clinical outcome, while "severe malnutrition" represents the worst.

Time frame
Baseline, 1 month, 3 months, and 6 months postoperatively
3

Complications

Rate of postoperative complications classified as Clavien-Dindo grade 2 or higher, specifically monitoring for delayed gastric emptying (DGE) and infectious complications (surgical site infection, pneumonia). The Clavien-Dindo classification is an ordinal scale used to grade surgical complications. The scale ranges from Grade I (minimum value, mild complication) to Grade V (maximum value, death of a patient). A higher grade indicates a more severe complication, representing a worse clinical outcome.

Time frame
Up to 30 days postoperatively
4

Glycemic Control

Frequency of hyperglycemic events, defined as plasma glucose levels of 180 mg/dL or higher, during the parenteral nutrition administration period.

Time frame
Postoperative Day 1 to Day 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Soonchunhyang University Hospital

Lead sponsor

JW Pharmaceutical

Collaborator

Source ClinicalTrials.gov
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