UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012745 |
|---|---|
| Receipt number | R000014848 |
| Scientific Title | Randomized controlled trial on the usefulness of ninjinyoeito (Kampo formula) for oxaliplatin-induced peripheral neuropathy and anemia (HOPE-2) |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2020/07/07 22:30:09 |
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Basic information
Public title
Randomized controlled trial on the usefulness of ninjinyoeito (Kampo formula) for oxaliplatin-induced peripheral neuropathy and anemia (HOPE-2)
Acronym
HOPE-2
Scientific Title
Randomized controlled trial on the usefulness of ninjinyoeito (Kampo formula) for oxaliplatin-induced peripheral neuropathy and anemia (HOPE-2)
Scientific Title:Acronym
HOPE-2
Region
| Japan |
Condition
Condition
Colorectal cancers
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether ninjinyoeito attenuates oxaliplatin-induced peripheral neuropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
peripheral neuropathy
Key secondary outcomes
hemoglobin concentration
neutrophil count
platelet count
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administraion of Tsumura ninjinyoeito extracted granule (for ethical use)
Interventions/Control_2
Non-administraion of Tsumura ninjinyoeito extracted granule (for ethical use)
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. Pathologically-proven colorectal cancers
2. Pathologically-proven stage IIIa or IIIb
3. Curative A resected
4. No history of chemotherapy, immunotherapy, or radiotherapy for pain control
5. More than 2 weeks after operation
6. PS 0-1
7. No severe dysfunction in major organs
8. Oral intake is possible
Key exclusion criteria
1. Blood transfusion or G-CSF administration within 7 days
2. Pleural effusion, ascites, or pericardial effusion, necessary for drainage
3. double cancers
4. drug hypersensitivity
5. diabetic neuropathy
6. diabetes mellitus, necessary for insulin therapy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Motoo |
Organization
Kanazawa Medical University
Division name
Department of Medical Oncology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Ishikawa 9200293, Japan
TEL
076-286-2211
motoo@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Motoo |
Organization
Kanazawa Medical University
Division name
Department of Medical Oncology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Ishikawa 9200293, japan
TEL
076-286-2211
Homepage URL
motoo@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Kanazawa Medical University Hospital
Address
1-1 Daigaku, Uchinada, Ishikawa 920-0293, Japan
Tel
076-286-2211
tiken@kanazawa-med.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
金沢医科大学病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32232692/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32232692/
Number of participants that the trial has enrolled
52
Results
Ninjin7yoeito significantly ameliorated the grade of oxaliplatin-induced cumulative peripheral neuropathy.
Results date posted
| 2020 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with colorectal cancer, receiving 8 cycles of XELOX regimen as postoperative adjuvant chemotherapy
Participant flow
Randomly assigned to either ninjin'yoeito group or control group
Adverse events
A case of pseudoaldosteronism possibly caused by ninjin'yoeito
Outcome measures
Grade of cumulative peripheral neuropathy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 02 | Day |
Last modified on
| 2020 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014848
