UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014207 |
|---|---|
| Receipt number | R000016544 |
| Scientific Title | Efficacy and safety of ninjinyoeito, Japanese Kampo medicine, on peripheral neuropathy and anemia induced by oxaliplatin |
| Date of disclosure of the study information | 2014/06/10 |
| Last modified on | 2014/07/19 17:48:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of ninjinyoeito, Japanese Kampo medicine, on peripheral neuropathy and anemia induced by oxaliplatin
Acronym
HOPE-2
Scientific Title
Efficacy and safety of ninjinyoeito, Japanese Kampo medicine, on peripheral neuropathy and anemia induced by oxaliplatin
Scientific Title:Acronym
HOPE-2
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Medicine in general | Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether ninjinyoeito prevents or attenuate peripheral neuropathy and anemia induced by oxaliplatin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
peripheral neuropathy
Key secondary outcomes
hemoglobin concentration
neutrophi count
platelet count
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FOLFOX or XELOX with ninjinyoeito
Interventions/Control_2
FOLFOX or XELOX without ninjinyoeito
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histopathologically-proven colorectal cancer
2. Pathological stage is stage IIIa or IIIb
3. Curative A operation was performed
4. No prior treatments such as chemotherapy, immunotherapy, or radiation therapy for pain control
Key exclusion criteria
1. Prior blood transfusion or G-CSF administration
2. Severe drug hypersensitivity
3. Peripheral neuropathy due to diabetes mellitus etc.
4. diabetes mellitus requiring insulin therapy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Motoo |
Organization
Kanazawa Medical University
Division name
Department of Medical Oncology
Zip code
Address
1-1 Daigakju, Uchinada, Ishikawa 920-0293
TEL
076-286-2211
motoo@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuho HIsamura |
Organization
Kanazawa Medical University
Division name
Department of Medical Oncology
Zip code
Address
1-1 Daigaku, Uchinada, Ishikawa 920-0293, Japan
TEL
076-286-2211
Homepage URL
hisamura@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
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
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
金沢医科大学病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 09 | Day |
Last modified on
| 2014 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016544
