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Phase III trial to evaluate EPA-enriched immunonutrition by perioperative Prosure in total gastrectomy for T2-T4a gastric cancer

Phase III trial to evaluate EPA-enriched immunonutrition by perioperative Prosure in total gastrectomy for T2-T4a gastric cancer - PIII-Prosure

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006380
Enrollment
120
Registered
2011-09-21
Start date
2011-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Oral supplementation of 2 packs of ProSure per day for 7 days before surgery and for 21 days after surgery No nutritional supplementation was given perioperatively

Sponsors

non-profit organization KSATTS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: i. Histologically proven adenocarcinoma of the stomach ii.Clinical T2-T4a and no distant metastasis iii.R0 resection is possible by open total gastrectomy iv.Enough oral intake v.Age ranging between 20 and 80. vi.ECOG performance status 0-1. vii.Not cancer of the remnant stomach viii.Suficient organ functions. iv.Written informed consent.

Exclusion criteria

Exclusion criteria: i.Treatment with drug including EPA (ethyl icosapentate) ii.Synchronous or metachronous cancer (synchronous multiple cancers in the stomach included). iii.Active inflammation which requires systemic treatment iv.Hemorrhagic tendency v.Lactose intolerance vi.Allergic reaction to milk and soy bean vii.Uncontrollable diabetes mellitus viii.Systemic treatment with corticosteroid ix.Unstable angina or cardiac infarction within 6 months x.Pulmonary disorder under oxygen xi.Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy. xii.Mental disorders which may affect ability or willingness to provide informed consent or abide by the study protocol

Design outcomes

Primary

MeasureTime frame
body weight loss at 1 and 3 months after surgery

Secondary

MeasureTime frame
Relative performance of ProSure, weight loss of lean body at 1 and 3 months after surgery, the lowest serum albumin level, quality of life, incidence of surgical morbidity and mortality, and incidence of surgical site infection.

Countries

Japan

Contacts

Public ContactTakaki Yoshikawa

Yokohama City University Medical Center Department of Gastrointestinal Surgery

yoshikawat@kcch.jp045-391-5761

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026