UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	EvaLuation of ChemoTherapy induced peRIpheral neuropathy by Current perception threshold
Title of the study (Brief title)	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	Satoshi TAMARU
Organization	Mie University Hospital
Division name	Medical oncology
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	Satoshi TAMARU
Organization	Mie University Hospital
Division name	Medical oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014032