PROGAIN Trial in Gastric Cancer Surgery

NCT07488611 | Recruiting Phase 3

• 1 other identifier: 2025-11-024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stomach (Gastric) Cancer

Keywords

Parenteral Nutrition; Gastrectomy; Nitrogen Balance; Protein enriched; Perioperative nutrition; Enhanced Recovery After Surgery; Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Nitrogen Balance

  Change in nitrogen balance, assessed by measuring 24-hour urinary urea nitrogen excretion and calculating total daily protein intake (from both oral diet and parenteral nutrition)

  Postoperative Day 5 (POD 5)

Secondary Outcomes (8)

• Skeletal Muscle Index (Sarcopenia Assessment)

  Baseline (preoperative), and 6 months postoperativel

• Nutritional Status Assessed by GLIM Criteria

  Baseline, 1 month, 3 months, and 6 months postoperatively

• Complications

  Up to 30 days postoperatively

• Glycemic Control

  Postoperative Day 1 to Day 5

• Functional Recovery

  Up to hospital discharge (expected average up to 7-10 days)

Study Arms (2)

Protein-enriched PPN

EXPERIMENTAL

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.

Drug: Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)

Standard PPN

ACTIVE COMPARATOR

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.

Drug: Standard peripheral parenteral nutrition (Winuf injection)

Interventions

Protein-enriched peripheral parenteral nutrition (Winuf A+ injection) DRUG

A novel, high-amino acid peripheral parenteral nutrition formulation (Winuf A+ injection; JW Pharmaceutical) designed to provide optimal protein delivery with lower glucose load. Administered intravenously.

Protein-enriched PPN

Standard peripheral parenteral nutrition (Winuf injection) DRUG

A conventional, standard 3-chamber peripheral parenteral nutrition formulation (Winuf injection; JW Pharmaceutical). Administered intravenously.

Standard PPN

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead
• JW Pharmaceutical: collaborator

Study Sites (1)

Soonchunhyang University Cheonan Hospital

Cheonan, Chungcheongnam-do, 31151, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Hyperphagia

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Geum Jong Song, MD, PhD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Hyuk Yun, MD, PhD

CONTACT

+82-10-3328-4380; 109206@schmc.ac.kr

Hyun Seob Shin

CONTACT

+82-10-7687-3350; 124909@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of gastrointestinal surgery

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 23, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal, subject to approval by the Institutional Review Board (IRB) and a formal data use agreement.

Locations

KR (1)