The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
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• Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study.
Locations
Other Locations
Republic of Korea
Soonchunhyang University Cheonan Hospital
RECRUITING
Cheonan
Contact Information
Primary
Jong Hyuk Yun, MD, PhD
109206@schmc.ac.kr
+82-10-3328-4380
Backup
Hyun Seob Shin
124909@schmc.ac.kr
+82-10-7687-3350
Time Frame
Start Date: 2026-02-13
Estimated Completion Date: 2028-03
Participants
Target number of participants: 100
Treatments
Experimental: Protein-enriched PPN
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.
Active_comparator: Standard PPN
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.
Related Therapeutic Areas
Sponsors
Collaborators: JW Pharmaceutical
Leads: Soonchunhyang University Hospital