UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011301
Receipt number R000013245
Scientific Title The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy
Date of disclosure of the study information 2013/07/29
Last modified on 2015/08/04 09:41:47

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Basic information

Public title

The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy

Acronym

The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy

Scientific Title

The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy

Scientific Title:Acronym

The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To reveal the efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Patient Neurotixicity Questionnaire(PNQ) and CTCAE v4.0

Key secondary outcomes

adverse event


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

Treatment

Type of intervention

Medicine

Interventions/Control_1

Lafutidine is administered orally at the dose of 10 mg twice daily for 9 weeks

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)breast cancer patient who are planning to chemotherapy using nab-paclitaxel
2)Cases it is considered to be performed to continue treatment with nab-paclitaxel 4 weeks or more
3)age: >=20 and =<75
4)peripheral neuropathy is not expressed
5)expected more than 6 months survival
6)written informed consent

Key exclusion criteria

1)with severe complications (such as liver failure, renal failure, heart failure)
2)with history of allergy
3)case of taking pregabalin
4)doctor's decision not to be registered to this study

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Itaru Endo

Organization

Yokohama City University Hospital

Division name

gastroenterological surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2800

Email

endoit@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sadatoshi SUGAE

Organization

Yokohama City University Hospital

Division name

Gastroenterological surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2800

Homepage URL


Email

sugae@f7.dion.ne.jp


Sponsor or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Yokohama Clinical Oncology Group

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

横浜市立大学附属病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
横須賀共済病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 29 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2013 Year 06 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 29 Day

Last follow-up date

2014 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 07 Month 29 Day

Last modified on

2015 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013245


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name