Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach (Gastric) Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Protein-enriched peripheral parenteral nutrition (Winuf A+ injection) | Drug | — | UNRESOLVED |
| Standard peripheral parenteral nutrition (Winuf injection) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Protein-enriched PPN
- 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.
- interventionNames
- Drug: Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)
- type
- ACTIVE_COMPARATOR
- label
- Standard PPN
- 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.
- interventionNames
- Drug: Standard peripheral parenteral nutrition (Winuf injection)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYun JH, Han M, Bae G, Shin H, Song G, Son M. The PROGAIN trial: A randomized controlled trial of high-protein peripheral parenteral nutrition on nitrogen balance and recovery after gastric cancer surgery - study protocol. PLoS One. 2026 Aug 7;21(8):e0355677. doi: 10.1371/journal.pone.0355677. eCollection 2026. PMID 42566454