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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004913
Receipt No. R000005780
Scientific Title A phase II study of menthol for chemotherapy induced peripheral neuropathy
Date of disclosure of the study information 2011/01/20
Last modified on 2012/02/20

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Basic information
Public title A phase II study of menthol for chemotherapy induced peripheral neuropathy
Acronym A phase II study of menthol for chemotherapy induced peripheral neuropathy
Scientific Title A phase II study of menthol for chemotherapy induced peripheral neuropathy
Scientific Title:Acronym A phase II study of menthol for chemotherapy induced peripheral neuropathy
Region
Japan

Condition
Condition chemotherapy induced peripheral neuropathy
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy oh menthol for chemotherapy induced peripheral neuropathy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes good response rate
compliance
safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 menthol, twice daily spread to affected areas and skin
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 1)Recieving chemotherapy for cacner.
2)symptomatic peripheral neuropathy (grade2,3,4 CTC-AE 4.0).
3)ECOG Performance status 0,1.
4)Able to administration of menthol.
5)Able to write neuropathy check sheat.
6)Life expectancy at least 3months.
7)All patients provided written informed consent before initiation of study-related procedures.
Key exclusion criteria 1)Sever skin disease.
2)Severe symptom due to cacner.
3)Severe toxicity indued by chemotherapy.
4)Other disease which causes peripheral neuropathy.
5)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Nakamura
Organization Aizawa Hospital
Division name Aizawa comprehensive cancer center
Zip code
Address 2-5-1, Honjo, Matsumoto city, Nagano
TEL 0263-33-8600
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masato Nakamura
Organization Aizawa Hospital
Division name Aizawa comprehensive cancer center
Zip code
Address 2-5-1, Honjo, Matsumoto city, Nagano
TEL 0263-33-8600
Homepage URL
Email geka-dr7@ai-hosp.or.jp

Sponsor
Institute Aizawa Hospital
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

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 20 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
2010 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
2012 Year 02 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 20 Day
Last modified on
2012 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005780

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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