UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012878