UMIN-CTR Clinical Trial

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

esophageal cancer, gastric cancer, colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Reduction of systemic inflammatory response, especially C-reactive protein

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Mie University

Institute

Department

Personal name

Organization

Mie University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

05

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

05

Month

16

Day

Last modified on

2018

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037180