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An exploratory intervention study on the effect of omega-3 fatty acid supplementation for systemic inflammatory response in gastrointestinal cancer patients: A multicenter study.

An exploratory intervention study on the effect of omega-3 fatty acid supplementation for systemic inflammatory response in gastrointestinal cancer patients: A multicenter study. - An exploratory intervention study on the effect of omega-3 fatty acid supplementation for systemic inflammatory response in gastrointestinal cancer patients: A multicenter study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032610
Enrollment
300
Registered
2018-05-17
Start date
2018-05-18
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

esophageal cancer, gastric cancer, colorectal cancer

Interventions

omega-3 fatty acid supplement PO 6.5g/day(including lipid 4g and omega-3 fatty acid 2.2g) No supplement taking

Sponsors

Mie University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who can take orally. 2. Patients who have no endogenous abnormality in the digestive organs or abdominal organs. 3. Patients planned to undergo surgery or chemotherapy, chemoradiotherapy, or palliative care. 4. Over 20 years old

Exclusion criteria

Exclusion criteria: 1. Patients with metastatic brain disease 2. Patients with immunological disorders 3. Patients with severe liver disease. a. Patient diagnosed as cirrhosis. b. Aspartate aminotransferase (AST) 100 U/L (in the case of liver metastasis Over 200 U/L) or more c. Alanine aminotransferase (ALT) 100 U/L (in the case of liver metastasis, 200U/L) or more d. Total bilirubin 2.0 mg/dL or more 4. Patients with clotting abnormalities. a. Prothrombin time International standard ratio (PT-INR) 1.5 or more (ie, in patients with warfarin, less than PT-INR 3.0) b. Activated partial thromboplastin time (APTT) prolongation of 46 seconds or more 5. Patients with decreased bone marrow function Hemoglobin less than 8 g/dl, neutrophil count 1000 /ul, platelets 75000 /ul 6. Patients taking EPA preparations due to underlying diseases 7.Patients receiving antiplatelets and anticoagulant therapy 8. Active bleeding lesions other than the target digestive organ cancer. It includes peptic ulcers and trauma. 9. Patients with ileus, bowel obstruction, or uncontrollable diarrhea 10. Patients with stroke such as cerebral hemorrhage or subarachnoid hemorrhage or patients with a history within 24 weeks before registration (excluding asymptomatic lacunar infarction) 11. Allergy to omega3 fatty acid component 12. Diabetic patients with poor control 13. Other patients who were judged inappropriate for the doctor

Design outcomes

Primary

MeasureTime frame
Reduction of systemic inflammatory response, especially C-reactive protein

Countries

Japan

Contacts

Public ContactHiroyuki Fujikawa

Mie University Graduate School of Medicine Department of Gastrointestinal and Pediatric Surgery

f0609@clin.medic.mie-u.ac.jp+81-59-231-5294

Outcome results

None listed

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