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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002773
Receipt No. R000003373
Scientific Title Phase I study of extracts from Lentinula edodes mycelia in advanced cancer patients
Date of disclosure of the study information 2009/11/17
Last modified on 2011/12/06

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Basic information
Public title Phase I study of extracts from Lentinula edodes mycelia in advanced cancer patients
Acronym Phase I study of extracts from Lentinula edodes mycelia in advanced cancer patients
Scientific Title Phase I study of extracts from Lentinula edodes mycelia in advanced cancer patients
Scientific Title:Acronym Phase I study of extracts from Lentinula edodes mycelia in advanced cancer patients
Region
Japan

Condition
Condition advanced cancer
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Endocrine surgery Breast surgery
Obsterics and gynecology Oto-rhino-laryngology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assessment of safety of extracts from Lentinula edodes mycelia
Basic objectives2 Others
Basic objectives -Others Assessment of immunoactivity
Assessment of quality of life
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety
Key secondary outcomes immunoactivity
quality of life

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 extracts from Lentinula edodes mycelia
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 Patient with advanced cancer
No severe organ function impairment
Performance Status 0-1
Patient who is able to take oral medications
written informed consent of the patient
Key exclusion criteria Pregnant female
Patient allergic to shiitake mushroom
Patient with ileus
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ohno
Organization Tokyo Women's Medical University
Division name IREIIMS
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ohno
Organization Tokyo Women's Medical University
Division name IREIIMS
Zip code
Address
TEL 03-3353-8111
Homepage URL
Email ohno@imcir.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Kobayashi Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Bio-Thera Clinic
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
2009 Year 11 Month 17 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
2009 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 17 Day
Last modified on
2011 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003373

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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