UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010988
Receipt number R000012862
Scientific Title The randomized controlled trial of the efficacy of goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.
Date of disclosure of the study information 2013/06/18
Last modified on 2021/12/20 15:20:31

* 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 goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.

Acronym

The efficacy of goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.

Scientific Title

The randomized controlled trial of the efficacy of goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.

Scientific Title:Acronym

The efficacy of goshajinkigan and lafutidine after mecobalamin 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 goshajinkigan 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

Goshajinkigan is administered orally at the dose of 2.5g 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 mecobalamin administered
3)with digestive symptom such as upper abdominal discomfort
4)written informed consent

Key exclusion criteria

1)not mecobalamin 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 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


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 18 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 31 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 18 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=R000012862


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name