A study to evaluate the efficacy of EPA enriched oral nutrition supplement (ONS) and to investigate useful biomarkers for the assessment in advanced gastrointestinal cancer patients

A study to evaluate the efficacy of EPA enriched oral nutrition supplement (ONS) and to investigate useful biomarkers for the assessment in advanced gastrointestinal cancer patients - A study to evaluate the efficacy of EPA enriched oral nutrition supplement (ONS) and to investigate useful biomarkers for the assessment in advanced gastrointestinal cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006941

Enrollment

Registered

2011-12-26

Start date

2012-01-01

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/Colon cancer

Interventions

2 packs of an EPA enriched oral nutrition supplement (ONS) per day for 14 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. GPS:1 or 2 2. Oral intake 3. No abnormality in digestive organs due to endogenous diseases 4. Patients who undergo chemotherapy or who are scheduled to undergo chemotherapy 5. Life expectancy more than 3 months 6. No serious complications

Exclusion criteria

Exclusion criteria: 1. Metastatic brain disorder 2. Immune disorder 3. Cardiac disease, liver failure, renal failure, and active disease of small intestine (e.g., Crohn's disease) 4. Gastrointestinal symptoms (e.g., Intestinal obstruction, gastrointestinal bleeding, etc) 5. Allergic to the ingredient (s) 6. Uncontrollable diabetes mellitus 7. Considered inadequate for the inclusion in the study by the physician

Design outcomes

Primary

Measure	Time frame
QOL (QOL-ACD) at before and 14days,28days after the administration of EPA	—

Secondary

Measure	Time frame
At before and 14days,28days after the administration of EPA 1) Nutrition status 2) Glasgow Prognostic Score (GPS) 3) The expression of cytokines	—

Countries

Japan

Contacts

Public ContactKouki Kuwabara

Saitama Medical Center, Saitama Medical University Department of Digestive Tract and General Surgery

47kkuwa@saitama-med.ac.jp049-228-3619

Outcome results

None listed

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