UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044092 |
|---|---|
| Receipt number | R000050352 |
| Scientific Title | The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma who received systemic chemotherapy (A single-center, single-arm, open-label trial) |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/05/01 16:25:42 |
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Basic information
Public title
The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma who received systemic chemotherapy (A single-center, single-arm, open-label trial)
Acronym
The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma
Scientific Title
The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma who received systemic chemotherapy (A single-center, single-arm, open-label trial)
Scientific Title:Acronym
The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma
Region
| Japan |
Condition
Condition
Advanced urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Ninjin'yoeito is a herbal medicine that has the potential to improve anorexia and prevent loss of skeletal muscle mass and strength. However, its effect on the prevention of worsening sarcopenia in patients who who receive systemic chemotherapies remains unknown. Therefore, we conduct a pilot study to investigate the effects of Ninjin'yoeito on sarcopenia in patients with advanced urothelial carcinoma who receive systemic chemotherapies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation of change in the area of psoas muscle 8 weeks after the study.
Key secondary outcomes
The evaluation of change in frailty, body composition, and serum grelin levels 4 and 8 weeks after the study.
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
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Priscribe Ninjin'yoeito 5-7.5 g/day orally for patients with advanced urothelial carcinoma who recieve platinum-based chemotherapy during 2 months
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with advanced urothelial carcinoma who recieve platinum-based chemotherapy (Age; 20-90 years)
2. Patients who understand and are willing to participate this study.
3. Patients without a severe general condition due to progressive disease.
4. Patients without an abnormality in liver function and serum potassium level.
5. Patients who do not take other harbal medicines which have supportive roles for cancer treatment.
Key exclusion criteria
1. Patients can not take a harbal medicine due to dysphagia and/or tube feeding.
2. Patients who have already took other harbal medicines which have supportive roles for cancer treatment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Teppei |
| Middle name | |
| Last name | Okamoto |
Organization
Hirosaki University hospital
Division name
Center for Clinical Trial Management
Zip code
036-8562
Address
Zaihu-cho 5 Hirosaki Aomori
TEL
0172335111
t-okamoto@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Okamoto |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Urology
Zip code
036-8562
Address
Zaihu-cho 5 Hirosaki Aomori
TEL
0172335111
Homepage URL
t-okamoto@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University hospital
Institute
Department
Personal name
Funding Source
Organization
Kracie Pharmaceutical, Ltd.
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
Hirosaki University hospital
Address
Zaihu-cho 5 Hirosaki Aomori
Tel
0172335111
t-okamoto@hirosaki-u.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
| 2021 | Year | 06 | 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
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 01 | Day |
Last modified on
| 2021 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050352
