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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006200
Receipt No. R000007332
Scientific Title Evaluation of micronutrients in chemo and chemoradiotherapy for esophageal cancer
Date of disclosure of the study information 2011/08/19
Last modified on 2013/01/29

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Basic information
Public title Evaluation of micronutrients in chemo and chemoradiotherapy for esophageal cancer
Acronym Evaluation of micronutorints in esophageal cancer
Scientific Title Evaluation of micronutrients in chemo and chemoradiotherapy for esophageal cancer
Scientific Title:Acronym Evaluation of micronutorints in esophageal cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of micronutritions in chemotherpy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of micronutritions in chemotherpy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Elemenmic
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) Esophageal cancer patietns to undergo chemo(radio)therapy with 5-FU and CDDP.
2) 20 years old and older
Key exclusion criteria 1) impossibility in oral intake
2) abnormality in minerals
3) severe liver dysfunction
4) severe renal dysfunction
5) abnormal metabolism of aminoacids
6) allergry for elemenmic
7) hemophilia
8) inappropriate case for a clinical trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba university
Division name Frontier Surgery
Zip code
Address 1-8-1, Inohana, chuoku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University
Division name Frontier Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23054866
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
2008 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
2012 Year 01 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 19 Day
Last modified on
2013 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007332

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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