UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022547 |
|---|---|
| Receipt number | R000025988 |
| Scientific Title | Safety and efficacy of Kamikihito for the treatment of anxiety and insomnia in castration resistant prostate cancer patients |
| Date of disclosure of the study information | 2016/06/02 |
| Last modified on | 2021/12/06 13:56:39 |
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Basic information
Public title
Safety and efficacy of Kamikihito for the treatment of anxiety and insomnia in castration resistant prostate cancer patients
Acronym
KAMIKIHITO study for castration resistant prostate cancer patients
Scientific Title
Safety and efficacy of Kamikihito for the treatment of anxiety and insomnia in castration resistant prostate cancer patients
Scientific Title:Acronym
KAMIKIHITO study for castration resistant prostate cancer patients
Region
| Japan |
Condition
Condition
Anxiety insomnia and fatigue induced by hormone therapy
Classification by specialty
| Medicine in general | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate cancer related fatigue objectively and efficacy of kamikihito for anxiety and insomnia and fatigue in cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Effect of kamikihito on anxiety and insomnia at pre, 4 weeks, 8 weeks and 12 weeks by questionnaire.
Key secondary outcomes
Effect of kamikihito on fatugue at pre, 4 weeks, 8 weeks and 12 weeks by questionnaire and objective evaluation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of kamikihito
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
Castration resistant prostate cancer patients under hormone therapy with anxiety and insomnia.
Key exclusion criteria
1)Heart disease
2)Severely lung disease
3)Cranial nerve disease with unconsciousness
4)Liver disease more than grade 2
5) Severely drug hypersensitivity
6)Kampo administration within 2 weeks
7) Not appropriate for the study at the physician's assessment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tamada |
Organization
Osaka City University
Division name
Urology
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka City
TEL
06-6645-3857
s-tamada@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Tamada |
Organization
Osaka City University
Division name
Urology
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka City
TEL
06-6645-3857
Homepage URL
s-tamada@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
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
TSUMURA Research Laboratories
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka City University Graduate School of Medicine
Address
1-4-3 Asahimachi, Abeno, Osaka 545-8585, Japan
Tel
06-6645-3456
ethics@med.osaka-cu.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/tkm2.1298
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/tkm2.1298
Number of participants that the trial has enrolled
11
Results
Kamikihito improved CFS and CES-D scores, thus improving fatigue and depression in enzalutamide-treated patients; however, it did not improve oxidative stress levels. Further, actigraphy showed prolongation of sleeping time, while the levels of various cytokines showed no change. Metabolomics analysis confirmed decrease in lipids and increase in amino acids that correlated with improvement in fatigue.
Results date posted
| 2021 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All participants provided written informed consent as a condition of enrollment in the trial.
Eleven patients undergoing treatment with enzalutamide for CRPC were included.
Participant flow
These patients were administered kamikihito, and evaluated for fatigue, depression, and insomnia, as described below.
Adverse events
Somnolence (one patient)
Outcome measures
fatigue, depression, oxidative stress, various cytokines, insomnia (actigraphy), metabolites
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2021 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025988
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| Registered date | File name |
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