Recruiting PHASE3 Stomach (Gastric) Cancer

New treatment option for Stomach (Gastric) Cancer

Official title PROGAIN Trial in Gastric Cancer Surgery

ClinicalTrials.gov ID: NCT07488611

What this study is testing

What is Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)?

Protein-enriched peripheral parenteral nutrition (Winuf A+ injection) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stomach (gastric) cancer.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 19 and older

You may be able to join if

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

You likely can't join if

  • Patients with uncontrolled severe systemic diseases (e.g., decompensated diabetes, cerebrovascular event within the last 6 months, sepsis, heart...
  • 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
See the full eligibility criteria
Who can 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.
What rules you out
  • 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 \ 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Cheonan, Chungcheongnam-do, South Korea

Compensation & support

A stipend or compensation may be offered.

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Cheonan, Chungcheongnam-do, South Korea. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.