UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015799 |
|---|---|
| Receipt number | R000018385 |
| Scientific Title | The establishment of evaluating method for general fatigue and the investigation of Kampo-medicine, Jyu-zen-ho-eki-tou, on general fatigue induced by cisplatin |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2014/12/01 00:09:46 |
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Basic information
Public title
The establishment of evaluating method for general fatigue and the investigation of Kampo-medicine, Jyu-zen-ho-eki-tou, on general fatigue induced by cisplatin
Acronym
Cisplatin-induced general fatigue and Kampo-medicine
Scientific Title
The establishment of evaluating method for general fatigue and the investigation of Kampo-medicine, Jyu-zen-ho-eki-tou, on general fatigue induced by cisplatin
Scientific Title:Acronym
Cisplatin-induced general fatigue and Kampo-medicine
Region
| Japan |
Condition
Condition
Urological patients with urothelial carcinoma, who will receive chemotherapy using cisplatin
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish a method to evaluate general fatigue induced by cisplatin
To evaluate a role of Kampo-drug, Jyu-zen-dai-ho-tou, for general fatigue
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer fatigue scale
Key secondary outcomes
Background of patinets (height, body weight, past history, drug, Hie-shou), Visual analogue scale of general fatigue and Hie-shou, achievement rate of chemotherapy, adverse event of chemotherapy, renal function, anti-cancer effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Jyu-zen-dai-ho-tou, 7.5g/day, p.o.
Interventions/Control_2
contorol
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1Urothelial carcinoma patients who will receive chemotherapy with cisplatine
Key exclusion criteria
Patients who did not agree with this trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Minagawa |
Organization
Shinshu University Hospital
Division name
Urology
Zip code
Address
Asahi 3-1-1 Matsumoto city, 390-8621, Japan
TEL
0263-37-2661
minagawat@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Minagawa |
Organization
Shinshu University Hospital
Division name
Urology
Zip code
Address
Asahi 3-1-1 Matsumoto city, 390-8621, Japan
TEL
0263-37-2661
Homepage URL
minagawat@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university hospital
Institute
Department
Personal name
Funding Source
Organization
Department of urology, shinshu university hospital
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
Address
Tel
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
| 2015 | Year | 01 | 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
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 01 | Day |
Last modified on
| 2014 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018385
