UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005338 |
|---|---|
| Receipt number | 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 21:07:34 |
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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
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
chishima@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006346
