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
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
Treatments tested in this trial
- Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)
- Standard peripheral parenteral nutrition (Winuf injection)
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Soonchunhyang University Hospital
Lead sponsor
JW Pharmaceutical
Collaborator
Source ClinicalTrials.gov