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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032610
Receipt No. R000037180
Scientific 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.
Date of disclosure of the study information 2018/05/17
Last modified on 2018/12/27

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Basic information
Public 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.
Acronym An exploratory intervention study on the effect of omega-3 fatty acid supplementation for systemic inflammatory response in gastrointestinal cancer patients: A multicenter study.
Scientific 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name 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
Zip code
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
1st name
Middle name
Last name Hiroyuki Fujikawa
Organization Mie University Graduate School of Medicine
Division name Department of Gastrointestinal and Pediatric Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 05 Month 17 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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