UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002773 |
|---|---|
| Receipt number | 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 12:22:50 |
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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 |
| Obstetrics 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
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
ohno@imcir.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003373
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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