UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Duloxetin for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients with depression.
Title of the study (Brief title)	Duloxetin study
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical efficacy and safety of duloxetine for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients with depression.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	prolongation of period of oxaliplatin treatment
Key secondary outcomes	evaluation of peripheral neuropath, QOL, safety, total dose of oxaliplatin

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	duloxetine
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	1) Written informed consent obtained from the patient 2) Physician judged adequate 3) Histlogically proven colorectal carcinoma 4) Patients with depression including cetuximab, or panitumumab 5) Gr2 peripheral neuropathy 6) Age>=20years 7) ECOG performance status of 0, 1 8) No prior chemotherapy and radiotherapy for other malignancies 9) Adequate hematologic, renal, hepatic and metabolic function :
Key exclusion criteria	1) pregnant or female intend to be pregnant, and male intend to make pregnant. 2) uncontrollable serious mental problem 3) peripheral neuropathy with other drug 4) uncontrolled diabetes mellitus 5) patients who receives antineuropathy therapy
Target sample size	25

Research contact person
Name of lead principal investigator	Akihito Tsuji
Organization	Kobe City Medical Center General Hospital
Division name	medical oncology
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL	078-302-4321
Email	t-kotake@kcho.jp

Public contact
Name of contact person	Takeshi Kotake
Organization	Kobe City Medical Center General Hospital
Division name	medical oncology
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL	078-302-4321
Homepage URL
Email	t-kotake@kcho.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization	Local Government
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	2014 Year 05 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 16 Day
Anticipated trial start date	2014 Year 05 Month 19 Day
Last follow-up date	2016 Year 03 Month 30 Day
Date of closure to data entry	2016 Year 03 Month 30 Day
Date trial data considered complete	2016 Year 03 Month 30 Day
Date analysis concluded	2016 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 16 Day
Last modified on	2016 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016274