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

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 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


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

Value
https://center6.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