NCT07488611RecruitingPhase 3
PROGAIN Trial in Gastric Cancer Surgery
The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 14 Mar 2026
- Start date
- 13 Feb 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- Soonchunhyang University Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07488611
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 110
- From 13 Feb 2026 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received intravenous parenteral nutrition within 7 days prior to randomization.
Other illness
- Patients with uncontrolled severe systemic diseases (e.g., decompensated diabetes, cerebrovascular event within the last 6 months, sepsis, heart failure).
Lab values
- 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
Other
- Patients deemed inappropriate for participation in this clinical trial by the investigator.
Who the study is looking for
- Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soonchunhyang University Cheonan Hospital Coordinator of this site? Confirm its status | Cheonan | South Korea | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.