The PROGAIN trial: A randomized controlled trial of high-protein peripheral parenteral nutrition on nitrogen balance and recovery after gastric cancer surgery - study protocol.

Authors

Jong Hyuk Yun, MinJee Han, GaRam Bae, Hyunsub Shin, GeumJong Song, MyoungWon Son

Published in

PloS one. Volume 21. Issue 8. Pages e0355677. Epub Aug 07, 2026.

Abstract

Patients undergoing curative gastrectomy for gastric cancer are vulnerable to perioperative protein loss, negative nitrogen balance and delayed recovery. Conventional peripheral parenteral nutrition (PN) formulations may not provide sufficient protein at clinically practical infusion volumes, and whether high-protein (amino acid-enriched) PN improves postoperative nitrogen balance after gastrectomy has not been tested in a randomized controlled trial. The PROGAIN trial evaluates the effect of perioperative high-protein PN on nitrogen balance and recovery outcomes in this population.
PROGAIN is a single-center, randomized, open-label, parallel-group superiority trial with blinded laboratory assessment and coded-group analysis of the primary endpoint. The trial will enroll 110 patients with gastric cancer scheduled for curative gastrectomy. Participants are allocated 1:1 to high-protein PN or conventional PN, administered through a peripheral intravenous line on the day before surgery and postoperative day (POD) 1 through POD 5. PN is delivered at a daily caloric target of 20 kcal/kg/day using a stepwise schedule informed by an institutional retrospective audit of oral intake. The primary outcome is nitrogen balance on POD 5, calculated using a simplified Blackburn equation. Secondary outcomes include nutritional indices, skeletal muscle index, glycemic control, postoperative complications classified by Clavien-Dindo grade and functional recovery measures. The primary analysis will compare the two arms using a two-sample t-test in the intention-to-treat population. The trial has 80% power to detect a between-group mean difference of 3 g/day at a two-sided α of 0.05.
The trial is approved by the Institutional Review Board of Soonchunhyang Cheonan Hospital and conducted in accordance with the Declaration of Helsinki and ICH-Good Clinical Practice. Findings will be disseminated through peer-reviewed publication, scientific meetings and results reporting on ClinicalTrials.gov.
ClinicalTrials.gov, NCT07488611.

PMID:
42566454
Bibliographic data and abstract were imported from PubMed on 08 Aug 2026.

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