UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The suppressant action of the surgical stress
Title of the study (Brief title)	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	Hisako Kubota
Organization	Kawasaki Medical school
Division name	Digestive Surgery
Address	577 Matsushima Kurasiki-city Okayama, Japan
TEL	086-462-1111
Email	kubota@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Hisako Kubota
Organization	Kawasaki Medical school
Division name	Digestive Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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