UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospectve study to evaluate the efficacy of pregabalin for chemotherapy-induced peripheral nueralgia
Title of the study (Brief title)	Pregabaalin for chemotherapy-induced peripheral nueralgia
Region	Japan

Condition
Condition	Patients who suffers from peripehral neuralgia which is induced by antineaoplastic agents that were adeministered for therapy of hematological malignancies
Classification by specialty	Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The object of this study is to evaluate the efficacy fo pregabalin by prospectively describing the effficacy of this agent who received pregabalin for chemotherapy-induced peripheral neuralgia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The rate of patients whose PNQ grade (neuralgia score) improved at the 4th week after administration of pregabalin
Key secondary outcomes	1. The rate of patients whose PNQ grade (neuralgia score) improved at the first, second, and third week after administration of pregabalin 2. The rate of patients whose McGill Pain Questionnaire score (which depicts qualitative properties of neuralgia) changed at the first, second, and third, and 4th week after administration of pregabalin. 3. The rate of patients whose VAS score improved at the first, second, and third week after administration of pregabalin

Base
Study type	Observational

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who received chemotherapeutic agents for hematological malignancies and suffer from sensory neural disturbances which are assumed to be induced by the chemotherapies.
Key exclusion criteria	1. decreased renal function (creatinine clearance equal to 60mL/min or less) 2. ocular disturbances including vision abnoramlity 3. underlying diabetes mellitus or postherpetic neuralgia 4. with previous history of pregabalin administration
Target sample size	50

Research contact person
Name of lead principal investigator	Yasuhito Nannya
Organization	Tokyo University Hospital
Division name	Dep. of Hematology and Oncology
Address	Hongo 7-3-1, Bunkyo-ku
TEL	+81-3-3815-5411
Email	ynanya-tky@umin.ac.jp

Public contact
Name of contact person	Yasuhito Nannya/Ryo Nasu
Organization	Tokyo University Hospital
Division name	Dep. of Hematology and Oncology
Address	Hongo 7-3-1, Bunkyo-ku
TEL	0338155411
Homepage URL
Email	ynanya-tky@umin.ac.jp

Sponsor
Institute	Tokyo University, Dep. of Hematology and Oncology
Institute
Department

Funding Source
Organization	Research funds, Tokyo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2011 Year 06 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 12 Month 16 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Doctors fill in the case report form which includes sex, age, underlying hematological diseases, history of therapy against the diease, and dose of pregabarin administered. Patients fill in the symptoms report form before and four times weekly after the administaration of pregabarin. Patients report the quantity and characters of neuralgia.

Management information
Registered date	2011 Year 05 Month 26 Day
Last modified on	2017 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006674