UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057261 |
|---|---|
| Receipt number | R000065354 |
| Scientific Title | Efficacy of Rikkunshito in preoperative patients with urological cancer |
| Date of disclosure of the study information | 2025/03/11 |
| Last modified on | 2025/09/10 10:18:53 |
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Basic information
Public title
Efficacy of Rikkunshito in preoperative patients with urological cancer
Acronym
Efficacy of Rikkunshito in preoperative patients with urological cancer
Scientific Title
Efficacy of Rikkunshito in preoperative patients with urological cancer
Scientific Title:Acronym
Efficacy of Rikkunshito in preoperative patients with urological cancer
Region
| Japan |
Condition
Condition
Urological cancer patients before surgery
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of Rikkunshito in patients undergoing surgery for urological cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Changes in EuroQol-5 and Dimension-5 scores
Key secondary outcomes
Frequency of perioperative complications
Change in Controlling Nutrition Score
Change in Mini Nutrition Assessment (total of patient and medical staff)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Among patients undergoing curative treatment for kidney cancer, prostate cancer, or bladder cancer, patients who score 14 or less on the Geriatric-8 simple geriatric functional assessment tool and who have a reduced food intake in question 1 (by only targeting patients who have a reduced food intake in question 1, we guarantee that the prescription of Rikkunshito will be covered by insurance) will be asked to take Tsumura Rikkunshito for one month before surgery, and we will examine whether their preoperative nutritional status has improved.
Study subjects will be given 7.5g of Tsumura Rikkunshito orally three times a day, before or between meals.
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years or older who scored 14 points or less on the Geriatric-8 simple tool for evaluating geriatric function
Patients who responded to question 1 of the Geriatric-8 simple tool for evaluating geriatric function that they had decreased their food intake
Patients scheduled to undergo radical or partial resection for kidney, prostate, or bladder cancer
Patients who understand the contents of the informed consent document and can sign it of their own free will
Key exclusion criteria
Pregnant and breastfeeding patients
Patients who have been confirmed to refuse to participate
Patients with dementia (PS2 or higher)
Patients who regularly visit or are hospitalized in a psychiatric and neurological department due to a psychiatric illness and are deemed to have difficulty participating in the study
Patients who are otherwise deemed ineligible by the principal investigator and co-investigators of this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 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
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
irb@bh.seichokai.or.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
| 2025 | Year | 03 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 03 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065354
