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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006718
Receipt No. 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

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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
Institute Kawasaki Medical school
Institute
Department

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
URL(English) https://upload.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


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