UMIN-CTR Clinical Trial

Basic information
Public title	Goshajinkigan for chemotherapy-induced peripheral neuropathy control : A systematic review
Acronym	Goshajinkigan for chemotherapy-induced peripheral neuropathy control : A systematic review
Scientific Title	Goshajinkigan for chemotherapy-induced peripheral neuropathy control : A systematic review
Scientific Title:Acronym	GCPNC
Region	Japan

Condition
Condition	chemotherapy-induced peripheral neuropathy
Classification by specialty	Surgery in general Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine whether goshajinkigan can be controlled for peripheral neuropathy caused by chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation index of peripheral neuropathy 1. CTCAE 2. DEB-NTC
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	An outcome report of peripheral neuropathy induced by cancer chemotherapy
Key exclusion criteria	Report on peripheral neuropathy induced by other than cancer chemotherapy as outcome
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Nakano
Organization	Yokohama University of Pharmacy
Division name	Dep. of Pharmacy
Zip code	245-0066
Address	601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN
TEL	045-859-1300
Email	m.nakano@hamayaku.ac.jp

Public contact
Name of contact person	1st name Kohsuke Middle name Last name Hayamizu
Organization	Yokohama University of Pharmacy
Division name	Dep. of Pharmacy
Zip code	245-0066
Address	601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN
TEL	045-859-1300
Homepage URL
Email	k.hayamizu@hamayaku.ac.jp

Sponsor
Institute	Yokohama University of Pharmacy
Institute
Department

Funding Source
Organization	Yokohama University of Pharmacy
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	Yokohama University of Pharmacy
Address	601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN
Tel	0458591300
Email	kohsuke_hayamizu@nissui.co.jp

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	2022 Year 12 Month 01 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	2019 Year 02 Month 25 Day
Date of IRB	2019 Year 02 Month 16 Day
Anticipated trial start date	2019 Year 02 Month 25 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	e-Search by Database is finished. Under selection of relevant papers.

Management information
Registered date	2019 Year 07 Month 01 Day
Last modified on	2019 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042441