UMIN-CTR Clinical Trial

Basic information
Official scientific title of the 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.
Title of the study (Brief title)	An exploratory intervention study on the effect of omega-3 fatty acid supplementation for systemic inflammatory response in gastrointestinal cancer patients: A multicenter study.
Region	Japan

Condition
Condition	esophageal cancer, gastric cancer, colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In patients with gastrointestinal cancer, we will investigate systemic inflammatory response, nutritional status, changes in concentration of resolvin and related metabolites by administration of DHA-enhanced omega-3 fatty acid supplement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reduction of systemic inflammatory response, especially C-reactive protein
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	omega-3 fatty acid supplement PO 6.5g/day(including lipid 4g and omega-3 fatty acid 2.2g)
Interventions/Control_2	No supplement taking
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	300

Research contact person
Name of lead principal investigator	Yuji Toiyama
Organization	Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	2-174 Edobashi, Tsu, Mie
TEL	+81-59-231-5294
Email	ytoi0725@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Hiroyuki Fujikawa
Organization	Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	2-174 Edobashi, Tsu, Mie
TEL	+81-59-231-5294
Homepage URL
Email	f0609@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University
Institute
Department

Funding Source
Organization	Mie University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 05 Month 17 Day
Anticipated trial start date	2018 Year 05 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 16 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037180