UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030515 |
|---|---|
| Receipt number | R000034836 |
| Scientific Title | Questionnaire survey on malnutrition when encapsulating Enzarutamide, in collaborat on with a pharmacy dispensing pharmacy at Hakodate Municipal Hospital -Part2- |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2021/12/27 07:42:58 |
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Basic information
Public title
Questionnaire survey on malnutrition when encapsulating Enzarutamide, in collaborat on with a pharmacy dispensing pharmacy at Hakodate Municipal Hospital -Part2-
Acronym
Survey on the feeling of fatigue of Enzarutamide, conducted in cooperation with the pre-dispensing pharmacy
Scientific Title
Questionnaire survey on malnutrition when encapsulating Enzarutamide, in collaborat on with a pharmacy dispensing pharmacy at Hakodate Municipal Hospital -Part2-
Scientific Title:Acronym
Survey on the feeling of fatigue of Enzarutamide, conducted in cooperation with the pre-dispensing pharmacy
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate fatigue with Enzaltamide
Basic objectives2
Others
Basic objectives -Others
Survevy on fatigue bydifference in usage
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Inverstigate whether the degree of fatigue differs depanding on usage
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Castration-resistant prostate cancer patiemts
Key exclusion criteria
Patients who do not agree with this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Sakata |
Organization
Hakodate Municipal Hospital
Division name
Pharmaceutical department
Zip code
0418680
Address
1-10-1,Minatochiou,Hakodate,Hokkaido,Japan
TEL
0138-43-2000
y-sakata@hospital.hakodate.hokkaido.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Sakata |
Organization
Hakodate Municipal Hospital
Division name
Pharmaceutical department
Zip code
0418680
Address
1-10-1,Minatochiou,Hakodate,Hokkaido,Japan
TEL
0138-43-2000
Homepage URL
y-sakata@hospital.hakodate.hokkaido.jp
Sponsor or person
Institute
Hakodate Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Hakodate Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakodate Municipal Hospital
Address
1-10-1,Minatochiou,Hakodate,Hokkaido,Japan
Tel
0138432000
y-sakata@hospital.hakodate.hokkaido.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | 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
| 2017 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As a questionnaire survevy, we use Cancer Faiting ue Scale
Management information
Registered date
| 2017 | Year | 12 | Month | 22 | Day |
Last modified on
| 2021 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034836
