UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031606 |
|---|---|
| Receipt number | 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 | 2021/03/24 16:41:24 |
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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
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
kshigehara0415@yahoo.co.jp
Sponsor or person
Institute
Department of Integrative Cancer Therapy and Urology,
Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
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
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
https://tau.amegroups.com/article/view/54511/html
Publication of results
Published
Result
URL related to results and publications
https://tau.amegroups.com/article/view/54511/html
Number of participants that the trial has enrolled
30
Results
Twenty-five patients completed the 12-week treatment. Hot flash strength significantly improved 4, 8, and 12 weeks after treatment. Their frequency was significantly reduced at the 8-week visit, and duration was significantly shorter after the 8-week visit. In addition, the score of the AMS somatic subscale was improved at the 8- and 12-week visits. Among the somatic items, questions 3 (excessive sweating) and 5 (increased need for sleep) were significantly improved.
Results date posted
| 2021 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The efficacy and safety of keishibukuryogan, a traditional Japanese medicine, were investigated for the treatment of hot flashes in prostate cancer (PC) patients receiving androgen deprivation therapy (ADT). Thirty patients were enrolled and orally administered 2.5 g keishibukuryogan three times daily for 12 weeks
Participant flow
After providing written informed consent, all patients underwent screening tests at a baseline visit.
Adverse events
Six adverse events including increased GOT value, nausea, general malaise, thirst, reduced appetite, and sleep disorder were observed in five cases, but all were mild. Two cases had adverse events that were undeniably associated with TJ-25 administration: nausea and general malaise in one case and sleep disorder in another. Treatment was discontinued in only one case of an adverse effect (sleep disorder).
Outcome measures
The frequency, strength, and duration of hot flashes were self-evaluated by the patients in a diary every 4 weeks. All patients also completed a questionnaire to determine their aging male symptoms (AMS) scale score and underwent blood biochemical testing.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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. Currently, the present study was finished, and primary analysis of data has been completed.
Management information
Registered date
| 2018 | Year | 03 | Month | 06 | Day |
Last modified on
| 2021 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036075
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