Protein-enriched peripheral IV nutrition after gastric cancer surgery
Official title: The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery
Run by Soonchunhyang University Hospital · NCT07488611 · Data updated 2026-11-12
This tests whether giving protein-enriched peripheral IV nutrition around the time of surgery helps adults recover faster after gastrectomy for stomach cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Soonchunhyang University Hospital Academic / other |
| Locations | 1 site (Cheonan, Chungcheongnam-do) |
| Status | Recruiting |
| Started | February 13, 2026 |
| Main results expected | February 2027 |
| Study ends | March 2028 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT07488611 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19 or older scheduled for gastrectomy for gastric cancer who can give informed consent and do not have uncontrolled severe systemic disease or excluded metabolic abnormalities are the intended participants.
✕Probably not a fit
Patients with uncontrolled severe systemic disease, significant metabolic abnormalities, recent intravenous parenteral nutrition, or those not undergoing gastrectomy are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized Phase 3 trial assigns adults undergoing gastrectomy for gastric cancer to receive either a protein-enriched peripheral parenteral nutrition formulation (Winuf A+ injection) or standard peripheral parenteral nutrition (Winuf injection) during the perioperative period. The primary outcome is nitrogen balance on postoperative day 5, and secondary outcomes include postoperative complications, time to recovery of oral intake, and short-term changes in nutritional status and body composition. The approach aims to bridge early postoperative nutritional gaps without central venous access by using higher-protein peripheral formulations that overcome osmolarity limits of traditional PPN. Investigators hypothesize that protein-enriched PPN will better blunt postoperative catabolism and reduce early muscle loss compared with standard PPN.
Why it matters
Potential benefit: If successful, patients might maintain better nitrogen balance, lose less muscle, and regain oral intake and function sooner after gastrectomy.
How similar studies have gone: While adequate perioperative protein delivery is known to support recovery after major surgery, protein-enriched peripheral parenteral formulations are recently developed and lack large Phase 3 evidence, so this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Soonchunhyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, South Korea Recruiting
Study contacts
- Principal investigator: Geum Jong Song, MD, PhD — Soonchunhyang University Cheonan Hospital
- Study coordinator: Jong Hyuk Yun, MD, PhD
- Email: 109206@schmc.ac.kr
- Phone: +82-10-3328-4380
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.