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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012003
Receipt No. 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

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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
Email 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
Email tamaru3@clin.medic.mie-u.ac.jp

Sponsor
Institute Medical oncology, Mie University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014032

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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