UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062749 |
|---|---|
| Receipt number | R000071842 |
| Scientific Title | The efficacy of Shakuyaku-kanzo-to in treating peripheral neuropathy caused by chemotherapy |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/31 15:28:43 |
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Basic information
Public title
The efficacy of Shakuyaku-kanzo-to in treating peripheral neuropathy caused by chemotherapy
Acronym
The efficacy of Shakuyaku-kanzo-to in treating peripheral neuropathy caused by chemotherapy
Scientific Title
The efficacy of Shakuyaku-kanzo-to in treating peripheral neuropathy caused by chemotherapy
Scientific Title:Acronym
The efficacy of Shakuyaku-kanzo-to in treating peripheral neuropathy caused by chemotherapy
Region
| Japan |
Condition
Condition
Patients undergoing chemotherapy for urological tumours
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of Shakuyaku-kanzo-to in treating peripheral neuropathy caused by chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in pain scores due to numbness as assessed by the VAS
Key secondary outcomes
Changes in numbness scores as measured by the VAS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Among patients undergoing chemotherapy for prostate cancer or urothelial carcinoma, those who reported pain due to numbness using the Visual Analogue Scale (VAS) were asked to take Tsumura Shakuyaku-kanzo-to, and the study will examine whether the pain caused by numbness and the numbness itself improved.
Study participants will be administered Tsumura Shakuyaku-kanzo-to orally at a dose of 7.5 g per day, divided into three doses, to be taken before meals or between meals. The duration of administration will vary depending on the efficacy observed.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with a VAS pain score of 1 or more due to numbness
2. Patients currently receiving chemotherapy for prostate cancer or urothelial carcinoma
3. Patients who are able to understand the contents of the informed consent document and sign the consent form of their own free will
Key exclusion criteria
1. Pregnant and breastfeeding patients
2. Patients who have expressly refused to participate
3. Patients with dementia (PS 2 or higher)
4. Patients who, due to a psychiatric disorder, are receiving regular outpatient treatment or are hospitalised in a psychiatric ward, and are deemed unable to participate in the trial
5. Any other patients deemed ineligible by the principal investigator or co-investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tamada |
Organization
Belland General Hospital
Division name
Urology
Zip code
599-8247
Address
500-3, Higashiyama, Naka-ku, Sakai City, Osaka
TEL
072-234-2001
gambaosakars@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Tamada |
Organization
Bell Land General Hospital
Division name
Urology
Zip code
599-8247
Address
500-3, Higashiyama, Naka-ku, Sakai City, Osaka
TEL
072-234-2001
Homepage URL
gambaosakars@yahoo.co.jp
Sponsor or person
Institute
Bell Land General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bell Land General Hospital
Address
500-3, Higashiyama, Naka-ku, Sakai City, Osaka
Tel
072-234-2001
irb@bh.seichokai.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
| 2026 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071842
