UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009956 |
|---|---|
| Receipt number | R000011660 |
| Scientific Title | Efficacy of goshajinkigan for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients |
| Date of disclosure of the study information | 2013/02/05 |
| Last modified on | 2018/09/05 20:20:30 |
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Basic information
Public title
Efficacy of goshajinkigan for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients
Acronym
Efficacy of goshajinkigan for peripheral neuropathy
Scientific Title
Efficacy of goshajinkigan for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients
Scientific Title:Acronym
Efficacy of goshajinkigan for peripheral neuropathy
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of goshajinkigan for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of goshajinkigan was graded as curative, effective, stabilizing, or deleterious. The relationships between grade of peripheral neuropathy and dose of oxaliplatin in the goshajinkigan and non-goshajinkigan groups were evaluated.
Key secondary outcomes
complication
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Colorectal cancer patients (N = 29) who received ≥4 weeks of goshajinkigan for oxaliplatin-induced peripheral neuropathy during chemotherapy at Kyoto Prefectural University of Medicine
Key exclusion criteria
Not applicable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohisa Yoshida |
Organization
Kyoto Prefectural Univeersity of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Prefectural Univeersity of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
naohisa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Chemotherapy unit, Kyoto Prefectural Univeersity of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chemotherapy unit, Kyoto Prefectural Univeersity of Medicine
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
| 2013 | Year | 02 | Month | 05 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
The results of our study will be published in the future.
Management information
Registered date
| 2013 | Year | 02 | Month | 05 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011660
