UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011007
Receipt No. 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 2014/07/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mm-kishi@hotmail.co.jp

Sponsor
Institute Department of breast and endocrine surgery, Meiwa Hospital
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2013 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 03 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
2013 Year 06 Month 19 Day
Last modified on
2014 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.