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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027749
Receipt No. R000031796
Scientific Title Questionnaire survey on malnutrition when encapsulating Enzartamide, in collaboration with a pharmacy dispensing pharmacy at Hakodate Municipal Hospital
Date of disclosure of the study information 2017/07/01
Last modified on 2018/06/14

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Basic information
Public title Questionnaire survey on malnutrition when encapsulating Enzartamide, in collaboration with a pharmacy dispensing pharmacy at Hakodate Municipal Hospital
Acronym Survey on the feeling of fatigue of enzartamide, conducted in cooperation with the pre-dispensing pharmacy
Scientific Title Questionnaire survey on malnutrition when encapsulating Enzartamide, in collaboration with a pharmacy dispensing pharmacy at Hakodate Municipal Hospital
Scientific Title:Acronym Survey on the feeling of fatigue of enzartamide, 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 Survey on fatigue by difference in usage
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Investigate whether the degree of fatigue differs depending on usage 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 patients
Key exclusion criteria Patients who do not agree with this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Sakata
Organization Hakodate Municipal Hospital
Division name Pharmaceutical department
Zip code
Address 1-10-1,Minatochiou,Hakodate,hokkaido,Japan
TEL 0138-43-2000
Email y-sakata@hospital.hakodate.hokkaido.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukio Sakata
Organization Hakodate Municipal Hospital
Division name Pharmaceutical department
Zip code
Address 1-10-1,Minatochiou,Hakodate,hokkaido,Japan
TEL 0138-43-2000
Homepage URL
Email y-sakata@hospital.hakodate.hokkaido.jp

Sponsor
Institute Hakodate Municipal Hospital
Institute
Department

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
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
2017 Year 07 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 05 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information As a questionnaire survey, we use Cancer Fatigue Scale

Management information
Registered date
2017 Year 06 Month 14 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031796

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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