UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011007 |
|---|---|
| Receipt number | R000012878 |
| Scientific Title | The randomized controlled trial of the efficacy of mecobalamin and lafutidine after goshajinkigan administered in breast cancer patients with chemotherapy-induced peripheral neuropathy. |
| Date of disclosure of the study information | 2013/06/19 |
| Last modified on | 2021/12/20 15:21:49 |
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Basic information
Public title
The randomized controlled trial of the efficacy of mecobalamin and lafutidine after goshajinkigan administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.
Acronym
The efficacy of mecobalamin and lafutidine after goshajinkigan administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.
Scientific Title
The randomized controlled trial of the efficacy of mecobalamin and lafutidine after goshajinkigan administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.
Scientific Title:Acronym
The efficacy of mecobalamin and lafutidine after goshajinkigan administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.
Region
| Japan |
Condition
Condition
chemotherapy-induced peripheral neuropathy
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of mecobalamin and lafutidine for chemotherapy-induced peripheral neuropathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The level of improvement of peripheral neuropathy is evaluated by Visual Analogue Scale (VAS).
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
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
Mecobalamin is administered orally at the dose of 500 microgram three times daily for 8 weeks.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)Breast cancer patient with taxane-induced peripheral neuropathy, which continued more than 1 month after chemotherapy with taxane (paclitaxel, nab-paclitaxel, docetaxel).
2)with residual peripheral neuropathy in spite of goshajinkigan administered
3)with digestive symptom such as upper abdominal discomfort
4)written informed consent
Key exclusion criteria
1)not goshajinkigan administered
2)with severe complications (such as liver failure, renal failure, heart failure)
3)with history of allergy
4)alredy adminstered with Goshajinkigan, Mecobalamin or Lafutidine.
5)with peripheral neuropathy for other cause (such as diabetes)
6)receiving drugs to influence peripheral neuropathy
7)doctore's decision not to be registered to this study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Kishimoto |
Organization
Meiwa Hospital
Division name
Department of breast and endocrine surgery
Zip code
Address
Kaminaruo-cho 4-31, Nishinomiya, Hyogo, in Japan
TEL
0798-47-8186
mm-kishi@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Kishimoto |
Organization
Meiwa Hospital
Division name
Department of breast and endocrine surgery
Zip code
Address
Kaminaruo-cho 4-31, Nishinomiya, Hyogo, in Japan
TEL
0798-47-8186
Homepage URL
mm-kishi@hotmail.co.jp
Sponsor or person
Institute
Department of breast and endocrine surgery, Meiwa 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
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
| 2013 | Year | 06 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | 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 | 06 | Month | 19 | Day |
Last modified on
| 2021 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012878
