An exploratory intervention study on the effect of omega-3 fatty acid supplementation for systemic inflammatory response in gastrointestinal cancer patients: A multicenter study.
- Conditions
- esophageal cancer, gastric cancer, colorectal cancer
- Registration Number
- JPRN-UMIN000032610
- Lead Sponsor
- Mie University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of systemic inflammatory response, especially C-reactive protein
- Secondary Outcome Measures
Name Time Method