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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014207
Receipt No. 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

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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
Email 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
Email hisamura@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016544

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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