UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012211
Receipt number R000014277
Scientific Title Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel
Date of disclosure of the study information 2014/01/01
Last modified on 2013/11/04 20:51:20

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Basic information

Public title

Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel

Acronym

Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel

Scientific Title

Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel

Scientific Title:Acronym

Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel

Region

Japan


Condition

Condition

The patient of gynecologic cancer treated with paclitaxel

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the preventive effect of neurotropin for neuropathy due to paclitaxel

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Level of sensory neuropathy

Key secondary outcomes

level of motor neuropathy


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

Prevention

Type of intervention

Medicine

Interventions/Control_1

neurotropin

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

80 years-old >

Gender

Female

Key inclusion criteria

The patients necessary for chemotherapy with paclitaxel doe to gynecologic cancer (vertical cancer, corpus cancer, ovarian cancer, tubal cancer and peritoneal cancer)

Key exclusion criteria

The patient with neuropathy due to other reason such as diabetes merits
THe patient with neuropathy due to progressive original disease

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Minoru Irahara

Organization

The University of Tokushima

Division name

Department of Obstetrics and Gynecology

Zip code


Address

3-18-15 Kuramoto-cho, Tokushima

TEL

088-633-7177

Email

irahara@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masato Nishimura

Organization

The University of Tokushima

Division name

Department of Obsterics and Gynecology

Zip code


Address

3-18-15 Kuramoto-cho Tokushima

TEL

088-633-7177

Homepage URL


Email

nishimura.masato@tokushima-u.ac.jp


Sponsor or person

Institute

Department of Obstetrics and Gynecology, The University of Tokushima

Institute

Department

Personal name



Funding Source

Organization

Department of Obstetrics and Gynecology, The University of Tokushima

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


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



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 01 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

Preinitiation

Date of protocol fixation

2013 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 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

2013 Year 11 Month 04 Day

Last modified on

2013 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014277


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name