UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058265 |
|---|---|
| Receipt number | R000066608 |
| Scientific Title | Therapeutic Effects of Ninjin'yoeito on Fatigue During Treatment for Advanced Prostate Cancer |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/24 16:53:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Therapeutic Effects of Ninjin'yoeito on Fatigue During Treatment for Advanced Prostate Cancer
Acronym
Therapeutic Effects of Ninjin'yoeito on Fatigue During Treatment for Advanced Prostate Cancer
Scientific Title
Therapeutic Effects of Ninjin'yoeito on Fatigue During Treatment for Advanced Prostate Cancer
Scientific Title:Acronym
Therapeutic Effects of Ninjin'yoeito on Fatigue During Treatment for Advanced Prostate Cancer
Region
| Japan |
Condition
Condition
Fatigue during treatment for advanced prostate cancer
Classification by specialty
| Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-fatigue effect of Ninjin'yoeito in patients with advanced prostate cancer who are receiving chemotherapy with novel antiandrogens such as abiraterone, enzalutamide, apalutamide, docetaxel and cabazitaxel, and who are suffering from fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Observe the value of the score of the questionnaire FACIT-F and its change before and after (after 1 month) the administration of Ninjin'yoeito
Observe changes in d-ROMs test and BAP test values before and after (after 1 month) administration of Ninjin'yoeito
Key secondary outcomes
Laboratory tests: items measured in daily practice (WBC, RBC, Hb, Hct, Plt, GOT, GPT, T-Bil, TP, ALB, BUN, CRE, CRP, Na, K, Ca, PSA, urine sugar, urine protein, urine occult blood, urine ketone bodies, urine red blood cells, urine white blood cells)
Adverse events (onset date, outcome, date of)
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
Patients must be diagnosed with advanced prostate cancer, use novel antiandrogenic agents or chemotherapy, and have fatigue/tiredness as side effects. Specifically, patients with a score of 1 or more in each of the FACIT-F categories of feeling tired and feeling fatigue will be targeted for participation in this study. After receiving a thorough explanation of their participation in this study, and with their full understanding and free and voluntary consent, the research subjects will receive 3 g of Ninjin'yoeito before each meal for 4 weeks as the scheduled oral treatment. Patients
Key exclusion criteria
Patients who are allergic to Kampo medicine
Patients who are already taking Kampo medicine internally
Other patients who are deemed inappropriate as research subjects by the principal investigator or subinvestigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | KAZUYOSHI |
| Middle name | |
| Last name | NAKAMURA |
Organization
Kimitsu Chuo Hospital
Division name
urology
Zip code
2928535
Address
1010 Sakurai, Kisarazu-shi, Chiba
TEL
0438361071
oarsmansoul2000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | KAZUYOSHI |
| Middle name | |
| Last name | NAKAMURA |
Organization
Kimitsu Chuo Hospital
Division name
urology
Zip code
2928535
Address
1010 Sakurai, Kisarazu-shi, Chiba
TEL
0438361071
Homepage URL
oarsmansoul2000@yahoo.co.jp
Sponsor or person
Institute
Dr. Kazuyoshi Nakamura, Department of Urology, Kimitsu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsumura Corporation
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
Kimitsu Chuo Hospital Research Ethics Committee
Address
1010 Sakurai, Kisarazu-shi, Chiba
Tel
0438361071
soumu@kc-hosp.or.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
| 2025 | Year | 06 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
currently under examination
Management information
Registered date
| 2025 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066608
