Protein-enriched peripheral IV nutrition after gastric cancer surgery
The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery
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 |
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Soonchunhyang University Hospital Academic / other |
| Locations | 1 site (Cheonan, Chungcheongnam-do) |
| Trial ID | NCT07488611 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cheonan, Chungcheongnam-do
- Soonchunhyang University Cheonan Hospital — Cheonan, Chungcheongnam-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Geum Jong Song, MD, PhD — Soonchunhyang University Hospital
- Study coordinator: Jong Hyuk Yun, MD, PhD
- Email: 109206@schmc.ac.kr
- Phone: +82-10-3328-4380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.