UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.
Title of the study (Brief title)	Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer
Region	Japan

Condition
Condition	Gastric cancer, breast cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Proportion of patients who was improved FACT-Taxane after administering pregabalin or duloxetine.
Key secondary outcomes	1) Adverse effect of pregabalin and duloxetine 2) Investigation of QOL (FACT-Taxane) 3)Current perception threshold(CPT)

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
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pregabalin is administered 75mg bid and increased gradually 150mg bid over 1week.
Interventions/Control_2	Duloxetine is administered 40mg qd. To begin administering 20mg qd, duloxetine is increased 40mg qd after an interval of more than 1 week.
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	1) Patients who have diagnosed gastric or breast cancer by cytodiagnosis or histological diagnosis. 2) Patients who have chemotherapy -related neurotoxicity (Grade2:CTCAE v4.0) and pain. 3) ECOG PS of 0 or 1 4) Adequate function of vital organs 5) Satisfactory oral feeding 6) Written informed consent
Key exclusion criteria	1) Serious drug allergy 2) Active double cancer 3) Active infection 4) Serious coexisting illness 5) History of pregabalin and duloxetine treatment 6) Severe renal dysfunction (Creatinine clearance <30mL/min) 7) Patients with using electronic implants or other cardiac pacemaker 8) Pregnant or lactating women or men who have desire father a child 9) Investigator's judgement
Target sample size	60

Research contact person
Name of lead principal investigator	Masashiro Goto
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL	072-683-1221
Email	in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person	Masashiro Goto
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL	072-683-1221
Homepage URL
Email	in2030@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Hospital
Institute
Department

Funding Source
Organization	Osaka Medical College Hospital
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	大阪医科大学付属病院（Osaka Medical College Hospital)

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 10 Day
Anticipated trial start date	2014 Year 11 Month 10 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

Management information
Registered date	2014 Year 12 Month 08 Day
Last modified on	2017 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018472