UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006718
Receipt number R000007709
Scientific Title The suppressant action of the surgical stress
Date of disclosure of the study information 2011/11/14
Last modified on 2017/02/20 07:23:22

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Basic information

Public title

The suppressant action of the surgical stress

Acronym

The suppressant action of the surgical stress

Scientific Title

The suppressant action of the surgical stress

Scientific Title:Acronym

The suppressant action of the surgical stress

Region

Japan


Condition

Condition

Esophageal cancer, Gasatric cancer, Colorectal cancer, Hepatocellular carcinoma, Colangiocellular carcinoma, Bile duct cancer, pancreatic carcinoma

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Surgery is known to cause oxidative stress, which can cause the failure of various organs. Surgery is also known to cause a type of metastasis called surgical oncotaxis. These complications can be suppressed by controlling oxidative stress. Nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) is activated by a variety of stressors. Eicosapentaenoic acid (EPA) is known to inhibit NF-kB activation. It is thought that EPA can suppress cytokine storm, oxidative stress and surgical oncotaxis. Oxidative stress can be measured with Free Radical Elective Evaluator (FREE) which evaluates the oxidant/antioxidant balance. FREE has a variety of tests: 1) the Diacron-reactive oxygen metabolites test (d-ROMs), which uses the capacity of hydroperoxides, and 2) biological antioxidant potential (BAP), which measures the action of the serum antioxidant potential. The aim of this study was to evaluate the oxidant/antioxidant balance before, during and after surgery, and to evaluate the ability of EPA to suppress oxidative stress when administered before surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate the ability of EPA to suppress oxidative stress when administered before surgery.

Key secondary outcomes

To evaluate the oxidant/antioxidant balance before, during and after surgery.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

To administere eicosapentaenoic acid before surgery

Interventions/Control_2


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) Cancer patients
(2) Written informed conscent to recieve this chemotherapy
(3) More than 20 years old
(4) Eastern Cooperative Oncology Groupe (ECOG) performance status of 0-2
(5) Life expectancy mor than 12 weeks
(6) The patients can take food oraly

Key exclusion criteria

(1) Infection or inflammatory case
(2) Severe heart disease
(3) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc
(4) others

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisako Kubota

Organization

Kawasaki Medical school

Division name

Digestive Surgery

Zip code


Address

577 Matsushima Kurasiki-city Okayama, Japan

TEL

086-462-1111

Email

kubota@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisako Kubota

Organization

Kawasaki Medical school

Division name

Digestive Surgery

Zip code


Address

577 Matsushima Kurasiki-city Okayama, Japan

TEL

086-462-1111

Homepage URL


Email

kubota@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical school

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical school

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

川崎医科大学(岡山県)


Other administrative information

Date of disclosure of the study information

2011 Year 11 Month 14 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

Completed

Date of protocol fixation

2011 Year 01 Month 11 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 12 Month 31 Day

Date trial data considered complete

2017 Year 12 Month 31 Day

Date analysis concluded

2017 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 11 Month 14 Day

Last modified on

2017 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007709


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name