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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031606
Receipt No. R000036075
Scientific Title Safety and efficacy of keishibukuryogan for hot flashes of patients with prostate cancer receiving hormonal therapy
Date of disclosure of the study information 2018/03/06
Last modified on 2019/03/15

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Basic information
Public title Safety and efficacy of keishibukuryogan for hot flashes of patients with prostate cancer receiving hormonal therapy
Acronym Keishibukuryogan study for prostate cancer patients with hot flashes
Scientific Title Safety and efficacy of keishibukuryogan for hot flashes of patients with prostate cancer receiving hormonal therapy
Scientific Title:Acronym Keishibukuryogan study for prostate cancer patients with hot flashes
Region
Japan

Condition
Condition Prostate cancer patients with hot flashes receiving hormonal therapy
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of keishibukuryogan for hot flashes of prostate cancer patients receiving hormonal therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Frequency , duration time and severity of hot flashes
Key secondary outcomes LOH-related symptoms(AMS score)
Cytokine level(IL-1beta, IL-2, IL-4, IL-6, IL-8, IL-10, INFalpha, IFNgamma, MCP-1(CCL2), MIP-1beta(CCL4),VEGF)
Hormone value(testosterone, DHEA, DHT, estradiol, progesterone)

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) Prostate cancer patients
2) Patients receiving hormonal therapy (androgen deprivation therapy)
3) Patients planning to administer keishibukuryogan for hot flashes
4) PS:0-2 and patients who can expect life prognosis for more than 1 year
5) Age: 20 years and over
6) Patients who can take oral administration of investigational drugs
7) Patients who provided written informed consent regarding study participation.
Key exclusion criteria Patients who have any of the following conditions are excluded.
1) Patients with severe mental illness
2)Patients who have serious complications (liver, kidney disease etc.)
3) Patients who have a history of allergies or side effects in kampo
4)Castration resistant prostate cancer patients
5) Patients who took prohibited concomitant drug or keishibukuryogan within 2 weeks
6) HIV, HBV, HCV positive patients
7) Others, including patients who judged by the investigator as ineligibility for entry
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Mizokami
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Integrative Cancer Therapy and Urology
Zip code 920-8641
Address 13-1 Takaramachi Kanazawa Ishikawa Japan
TEL 076-265-2393
Email mizokami@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Kazuyoshi
Middle name
Last name Shigehara
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Integrative Cancer Therapy and Urology
Zip code 920-8641
Address 13-1 Takaramachi Kanazawa Ishikawa Japan
TEL 076-265-2393
Homepage URL
Email kshigehara0415@yahoo.co.jp

Sponsor
Institute Department of Integrative Cancer Therapy and Urology,
Kanazawa University Graduate School of Medical Science
Institute
Department

Funding Source
Organization TSUMURA & CO.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Innovative Clinical Research Center, Kanazawa University
Address 13-1, Takaramachi, Kanazawa, Ishikawa
Tel 076-265-2000
Email crc.irb-knz@esct.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 03 Month 06 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 30
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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 18 Day
Date of IRB
2018 Year 01 Month 17 Day
Anticipated trial start date
2018 Year 03 Month 13 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
2019 Year 03 Month 07 Day
Date trial data considered complete
2019 Year 03 Month 11 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information To evaluate safety and efficacy of keishibukuryogan for hot flashes of prostate cancer patients receiving hormonal therapy

Management information
Registered date
2018 Year 03 Month 06 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036075

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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