PROGAIN Trial in Gastric Cancer Surgery (NCT07488611) | Clinical Trial Compass
RecruitingPhase 3
PROGAIN Trial in Gastric Cancer Surgery
South Korea110 participantsStarted 2026-02-13
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.