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
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
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
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
