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
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
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
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
