UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009655 |
|---|---|
| Receipt number | R000011333 |
| Scientific Title | Preventing effect of 1.35% menthol for oxaliplatin induced neurotoxicity |
| Date of disclosure of the study information | 2012/12/28 |
| Last modified on | 2015/06/29 10:08:50 |
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Basic information
Public title
Preventing effect of 1.35% menthol for oxaliplatin induced neurotoxicity
Acronym
Preventing effect of 1.35% menthol for oxaliplatin induced neurotoxicity
Scientific Title
Preventing effect of 1.35% menthol for oxaliplatin induced neurotoxicity
Scientific Title:Acronym
Preventing effect of 1.35% menthol for oxaliplatin induced neurotoxicity
Region
| Japan |
Condition
Condition
coorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate preventing effect of 1.35% menthol for oxaliplatin induced neurotoxicity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
grade2 neurotoxity rate at total dose of 500mg/m2 of oxaliplatin
Key secondary outcomes
compliance of questionaire
compliance of oxaliplatin including chemotherapy
continuous rate of 1.35% menthol
safety of 1.35% menthol
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1.35% menthol
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) ongoing oxaliplatin including chemotherapy
2) do not have neurotoxity causing other chemotherapy regimen
3) ECOG PS 0,1
4) able to use menthol
5) able to answer to questionaire
6) life expetancy over 3months
7) written informed concent
Key exclusion criteria
1) dificult to use menthol due to other skin trouble
2) uncontrollable symptom due to cancer
3) uncontrollable symptom due to adverse events
4) other reasons causing neurotoxicity
5) not apropriate to registration
Target sample size
32
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
Honjo 2-5-1, Matsumoto City, Nagano
TEL
+81-263-33-8600
geka-dr7@ai-hosp.or.jp
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
Honjo 2-5-1, Matsumoto City, Nagano
TEL
+81-263-33-8600
Homepage URL
geka-dr7@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Aizawa Hospital
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
| 2012 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | 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
Management information
Registered date
| 2012 | Year | 12 | Month | 28 | Day |
Last modified on
| 2015 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011333
