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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005338
Receipt No. R000006346
Scientific Title The efficacy of lafutidine in patients with chemotherapy-induced peripheral neuropathy treated with a taxane.
Date of disclosure of the study information 2011/03/29
Last modified on 2014/01/10

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Basic information
Public title The efficacy of lafutidine in patients with chemotherapy-induced peripheral neuropathy treated with a taxane.
Acronym The efficacy of lafutidine in patients with chemotherapy-induced peripheral neuropathy treated with a taxane.
Scientific Title The efficacy of lafutidine in patients with chemotherapy-induced peripheral neuropathy treated with a taxane.
Scientific Title:Acronym The efficacy of lafutidine in patients with chemotherapy-induced peripheral neuropathy treated with a taxane.
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy of lafutidine for chemotherapy -induced peripheral neuropaty
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The level of improvement of peripheral neuropathy is evaluated by Short-form McGill Pain Questionnaire(SF-MPQ), Patient Neurotoxity Questionnaire(PNQ) and CTCAE v4.0
Key secondary outcomes Quality of life, Safety

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 8 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 Female
Key inclusion criteria 1)breast cancer patient with taxane-induced peripheral neuropathy (>=Grade2), which continued more than 1 month
2)receiving chemotherapy and scheduled to receive same regimen
3)with digestive symptom such as upper abdominal discomfort by treatment
4)age: >=20 and =<75
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)administration of Lafutidine within 2weeks before prior to treatment
4)receiving drugs to influence peripheral neuropathy
5)with peripheral neuropathy for other cause (such as severe edema, diabetes, vitamin B12 deficiency)
6)doctor's decision not to be registered to this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Chishima
Organization Yokohama City University Hospital
Division name Breast surgery
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2650
Email chishima@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Chishima
Organization Yokohama City University Hospital
Division name Breast surgery
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2650
Homepage URL
Email chishima@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
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

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 29 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 Completed
Date of protocol fixation
2010 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 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
2011 Year 03 Month 29 Day
Last modified on
2014 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006346

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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