UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012003 |
|---|---|
| Receipt number | R000014032 |
| Scientific Title | EvaLuation of ChemoTherapy induced peRIpheral neuropathy by Current perception threshold |
| Date of disclosure of the study information | 2013/10/18 |
| Last modified on | 2017/10/22 12:43:57 |
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Basic information
Public title
EvaLuation of ChemoTherapy induced peRIpheral neuropathy by Current perception threshold
Acronym
ELCTRIC
Scientific Title
EvaLuation of ChemoTherapy induced peRIpheral neuropathy by Current perception threshold
Scientific Title:Acronym
ELCTRIC
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of current perception threshold for chemotherapy induced peripheral neuropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
relation of patients evaluation and current perception threshold
Key secondary outcomes
Relation of CTCAE, patients evaluation and the rate of current perception threshold
Relation of CTCAE, patients evaluation and current perception threshold
Amount of anticancer agents
The site and period of onset of peripheral neuropathy
Safety
Time to improvement for chemotherapy induced peripheral neuropathy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with cancer
2) Patients who are going to be treated or treated by anticancer agents which inducing peripheral neuropathy
3) 20 years old or more
4) Signed informed consent
Key exclusion criteria
1) Patients who are thought to have palsy of brachial nerve
2) Edema on the diseased side
3) patients who needs treatment for increased pressure on the brain or emergency radiation
4) Pregnant, nursing women, women who are willing to be pregnant
5) Patients with diabetes mellitus
6) Determination as contraindication by doctors
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi TAMARU |
Organization
Mie University Hospital
Division name
Medical oncology
Zip code
Address
2-174 Edobashi Tsu, Mie 514-8507, Japan
TEL
059-232-1111
tamaru3@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi TAMARU |
Organization
Mie University Hospital
Division name
Medical oncology
Zip code
Address
2-174 Edobashi Tsu, Mie 514-8507, Japan
TEL
059-232-1111
Homepage URL
tamaru3@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Medical oncology, Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical oncology , Mie University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 18 | 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 | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
relation of patients evaluation and current perception threshold
Management information
Registered date
| 2013 | Year | 10 | Month | 09 | Day |
Last modified on
| 2017 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014032
