Stomach (Gastric) CancerPhase 3PROGAINNCT07488611
PROGAIN Trial in Gastric Cancer Surgery
A Phase 3 study testing Protein-enriched peripheral parenteral nutrition (Winuf A+ injection) and Standard peripheral parenteral nutrition (Winuf injection) in people with Stomach (Gastric) Cancer, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stomach (Gastric) Cancer
- What is being tested?
- Protein-enriched peripheral parenteral nutrition (Winuf A+ injection) and Standard peripheral parenteral nutrition (Winuf injection)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Feb 2026to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Soonchunhyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, 31151
Jong Hyuk Yun, MD, PhD, +82-10-3328-4380, 109206@schmc.ac.kr
About this study
Official title: The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery
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.
Read the detailed description
Gastrectomy for gastric cancer induces a significant postoperative catabolic state, making adequate protein delivery crucial for optimal tissue healing and recovery. In the modern era of Enhanced Recovery After Surgery (ERAS) protocols, the routine use of central venous catheters for total parenteral nutrition (CPN) is heavily discouraged due to its invasiveness, infection risks, and hindrance to early mobilization. Consequently, Supplemental Parenteral Nutrition (SPN) via a peripheral route has emerged as the preferred strategy to bridge the nutritional gap when early oral intake is insufficient.
However, traditional standard peripheral parenteral nutrition (PPN) is inherently limited by osmolarity constraints to prevent peripheral phlebitis. This physical restriction often results in a critically inadequate supply of amino acids, failing to meet the heightened protein demands required to reverse acute postoperative catabolism and prevent rapid muscle depletion.
Recently, novel protein-enriched peripheral parenteral formulations have been developed to overcome this exact limitation, allowing for a higher, optimal amino acid load to be delivered safely via peripheral veins. The PROGAIN trial aims to evaluate the clinical impact of these advanced formulations. The investigators hypothesize that utilizing protein-enriched PPN, compared to standard PPN, will effectively blunt the catabolic response, significantly improve postoperative nitrogen balance, and facilitate earlier functional recovery in gastric cancer patients without compromising the principles of the ERAS pathway.
- Conditions
- Stomach (Gastric) Cancer
- Being tested
- Protein-enriched peripheral parenteral nutrition (Winuf A+ injection), Standard peripheral parenteral nutrition (Winuf injection)
- Keywords
- Parenteral Nutrition, Gastrectomy, Nitrogen Balance, Protein enriched, Perioperative nutrition, Enhanced Recovery After Surgery, Stomach Neoplasms
- Medical subject headings
- Stomach Neoplasms, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard peripheral parenteral nutrition (Winuf injection)Drug
A conventional, standard 3-chamber peripheral parenteral nutrition formulation (Winuf injection; JW Pharmaceutical). Administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard peripheral parenteral nutrition (Winuf injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Postoperative Day 5 (POD 5)
Secondary outcomes (8)
Skeletal Muscle Index (Sarcopenia Assessment)
Quantitative changes in skeletal muscle mass evaluated using the Skeletal Muscle Index (SMI). SMI is a continuous physiological measurement derived from cross-sectional imaging (such as abdominal computed tomography) and/or bioelectrical impedance analysis (BIA). Because it is a continuous physiological variable, there are no predefined minimum or maximum values on a scale. Higher SMI values indicate greater skeletal muscle mass, representing a better clinical outcome (prevention of muscle depletion).
Measured: Baseline (preoperative), and 6 months postoperativel
Nutritional Status Assessed by GLIM Criteria
Change in nutritional status evaluated using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Participants will be categorized into normal nutritional status, moderate malnutrition, or severe malnutrition. This is a categorical assessment, not a numerical scale with minimum or maximum values. The "normal nutritional status" category represents the best clinical outcome, while "severe malnutrition" represents the worst.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively
Complications
Rate of postoperative complications classified as Clavien-Dindo grade 2 or higher, specifically monitoring for delayed gastric emptying (DGE) and infectious complications (surgical site infection, pneumonia). The Clavien-Dindo classification is an ordinal scale used to grade surgical complications. The scale ranges from Grade I (minimum value, mild complication) to Grade V (maximum value, death of a patient). A higher grade indicates a more severe complication, representing a worse clinical outcome.
Measured: Up to 30 days postoperatively
Glycemic Control
Frequency of hyperglycemic events, defined as plasma glucose levels of 180 mg/dL or higher, during the parenteral nutrition administration period.
Measured: Postoperative Day 1 to Day 5
Functional Recovery
Recovery of Oral Intake, Length of Hospital Stay
Measured: Up to hospital discharge (expected average up to 7-10 days)
Prognostic Nutritional Index (PNI)
Change in the Prognostic Nutritional Index (PNI), calculated based on serum albumin concentration and total peripheral lymphocyte count. Because it is a continuous physiological calculated index, there are no predefined minimum or maximum values on a scale. Higher PNI values indicate better nutritional and immunological status, representing a better clinical outcome.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively
C-Reactive Protein to Albumin Ratio (CAR)
Change in the C-Reactive Protein to Albumin Ratio (CAR), calculated by dividing the serum C-reactive protein (CRP) level by the serum albumin level. This is a continuous physiological ratio, thus there are no predefined minimum or maximum values. Lower CAR values indicate lower systemic inflammation and better nutritional status, representing a better clinical outcome.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively
Modified Glasgow Prognostic Score (mGPS)
Change in the modified Glasgow Prognostic Score (mGPS), an inflammation-based prognostic score based on serum CRP and albumin thresholds. The mGPS is an ordinal scale with predefined values of 0, 1, or 2 (minimum value: 0, maximum value: 2). A lower score indicates a lower level of systemic inflammation, representing a better clinical outcome (0 is the best outcome, 2 is the worst outcome).
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start13 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach (Gastric) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- JW Pharmaceutical
- Responsible party
- Principal investigator, Geum Jong Song, Soonchunhyang University Hospital
- Investigators
- Geum Jong Song, MD, PhD, Principal investigator, Soonchunhyang University Cheonan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488611
- Sponsor's protocol ID
- 2025-11-024
- Acronym
- PROGAIN
- Status last verified
- May 2026
- First submitted
- 14 Mar 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article will be shared upon reasonable request to the corresponding author.
Publications
Yun JH, Han M, Bae G, Shin H, Song G, Son M. The PROGAIN trial: A randomized controlled trial of high-protein peripheral parenteral nutrition on nitrogen balance and recovery after gastric cancer surgery - study protocol. PLoS One. 2026 Aug 7;21(8):e0355677. doi: 10.1371/journal.pone.0355677. eCollection 2026.
PubMed 42566454
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT07488611
- Acronym / sponsor ID
- PROGAIN / 2025-11-024
- Conditions
- Stomach (Gastric) Cancer
- Keywords
- Parenteral Nutrition, Gastrectomy, Nitrogen Balance, Protein enriched, Perioperative nutrition, Enhanced Recovery After Surgery, Stomach Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Collaborators
- JW Pharmaceutical
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gastrectomy for gastric cancer induces a significant postoperative catabolic state, making adequate protein delivery crucial for optimal tissue healing and recovery. In the modern era of Enhanced Recovery After Surgery (ERAS) protocols, the routine use of central venous catheters for total parenteral nutrition (CPN) is heavily discouraged due to its invasiveness, infection risks, and hindrance to early mobilization. Consequently, Supplemental Parenteral Nutrition (SPN) via a peripheral route has emerged as the preferred strategy to bridge the nutritional gap when early oral intake is insufficient.
However, traditional standard peripheral parenteral nutrition (PPN) is inherently limited by osmolarity constraints to prevent peripheral phlebitis. This physical restriction often results in a critically inadequate supply of amino acids, failing to meet the heightened protein demands required to reverse acute postoperative catabolism and prevent rapid muscle depletion.
Recently, novel protein-enriched peripheral parenteral formulations have been developed to overcome this exact limitation, allowing for a higher, optimal amino acid load to be delivered safely via peripheral veins. The PROGAIN trial aims to evaluate the clinical impact of these advanced formulations. The investigators hypothesize that utilizing protein-enriched PPN, compared to standard PPN, will effectively blunt the catabolic response, significantly improve postoperative nitrogen balance, and facilitate earlier functional recovery in gastric cancer patients without compromising the principles of the ERAS pathway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein-enriched PPN | Experimental | Drug: Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)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. |
| Standard PPN | Active comparator | Drug: Standard peripheral parenteral nutrition (Winuf injection)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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study.
Key exclusion criteria (13 listed)
- 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:
- Patients deemed inappropriate for participation in this clinical trial by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)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. | Drug | Protein-enriched PPN |
| Standard peripheral parenteral nutrition (Winuf injection)A conventional, standard 3-chamber peripheral parenteral nutrition formulation (Winuf injection; JW Pharmaceutical). Administered intravenously. | Drug | Standard PPN |
Primary outcome
Nitrogen Balance
Time frame: Postoperative Day 5 (POD 5)
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)
8 secondary outcomes
Skeletal Muscle Index (Sarcopenia Assessment)
Time frame: Baseline (preoperative), and 6 months postoperativel
Nutritional Status Assessed by GLIM Criteria
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
Complications
Time frame: Up to 30 days postoperatively
Glycemic Control
Time frame: Postoperative Day 1 to Day 5
Functional Recovery
Time frame: Up to hospital discharge (expected average up to 7-10 days)
Prognostic Nutritional Index (PNI)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
C-Reactive Protein to Albumin Ratio (CAR)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
Modified Glasgow Prognostic Score (mGPS)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 42566454Yun JH, Han M, Bae G, Shin H, Song G, Son M. The PROGAIN trial: A randomized controlled trial of high-protein peripheral parenteral nutrition on nitrogen balance and recovery after gastric cancer surgery - study protocol. PLoS One. 2026 Aug 7;21(8):e0355677. doi: 10.1371/journal.pone.0355677. eCollection 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article will be shared upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Geum Jong Song, MD, PhD principal investigator
Soonchunhyang University Cheonan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Protein-enriched peripheral parenteral nutrition (Winuf A+ injection) and Standard peripheral parenteral nutrition (Winuf injection) in people with Stomach (Gastric) Cancer, run by Soonchunhyang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jong Hyuk Yun, MD, PhD (+82-10-3328-4380, 109206@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nitrogen Balance (time frame: Postoperative Day 5 (POD 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07488611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.