UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030120 |
|---|---|
| Receipt number | R000034390 |
| Scientific Title | Feasibility study for chemobrain |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2023/11/30 18:52:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility study for chemobrain
Acronym
Feasibility study for chemobrain
Scientific Title
Feasibility study for chemobrain
Scientific Title:Acronym
Feasibility study for chemobrain
Region
| Japan |
Condition
Condition
Cancer patients
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
prevention of chemotherapy-induced cognitive impairment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
biomarker for axonal damage
Key secondary outcomes
safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of neuroprotective agent
Interventions/Control_2
coadministration with chemotherapy
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cancer patients receiving chemotherapy
Key exclusion criteria
severe cognitive decline
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sumitani |
Organization
The University of Tokyo
Division name
Hospital
Zip code
113-0033
Address
7-3-1 Bunkyo, Hongo, Tokyo 113-0033 Japan
TEL
03-3815-5411
sumitanim-ane@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sumitani |
Organization
The University of Tokyo
Division name
Hospital
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo, Tokyo 113-0033 Japan
TEL
03-3815-5411
Homepage URL
sumitanim-ane@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo, Faculty of Medicine, Ethics committee
Address
Hongo 7-3-1, Bunkyo, Tokyo, Japan
Tel
03-3815-5411
sumitanim-ane@h.u-tokyo.ac.jp
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
東京大学医学部附属病院（東京都）、聖路加国際病院（東京都）、筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
blind
Publication of results
Unpublished
Result
URL related to results and publications
blind
Number of participants that the trial has enrolled
0
Results
blind
Results date posted
| 2023 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
blind
Participant flow
blind
Adverse events
blind
Outcome measures
blind
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034390
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
