the main goal of this study is to examine the efficacy of duloxetine in prevention of taxan- based chemotherapy induced neuropathy.
116 pateints, scheduled to undergo adjuvant paclitaxel therapy for breast cancer,will randomized to receive 30 mg duloxetine or plasebo in the first day of receiving paclitaxel till two weeks after finishing the last dose.in the first day and 6,12 and 24 weeks after that,patient will undergo neurologic examination and quality of life survey, based on NCI-CTCAE and fact-taxane questionnaire.
at the end the data will analyzed and documented.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050227711N1
Registration date:2016-08-28, 1395/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Azin Ahmari
Name of organization / entity
Shahid Beheshty University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 88059015
Email address
azin_ahmari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Breast Cancer Research Center of Jahad Daneshgahi
Tadbir Kalay-e Jam Pharmaceutical Company
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
efficacy of Duloxetine for prevention of chemotherapy induced neuropathy in breast cancer patients
Public title
efficacy of Duloxetine for prevention of chemotherapy induced neuropathy
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:
-patient receiving paclitaxel
-it is the first dose of paclitaxel
-prior or ongoing treatment with other neurotoxic chemotherapic agents is not allowed
-participants with out any documented medical history of nerve compression, leptomeningeal carcinomatosis, severe depression, suicidal idea, bipolar disease, alcohol abuse, glaucoma, diabetes, thyroid abnormality, markedly abnormal renal or liver function tests
- not taking any medicine interfere in serotonin level
-not taking any analgesic medicine routinely in two weeks before entering the trial
exclusion criteria:
-sever complications with duloxetine
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Siences
Street address
Breast Cancer Research Center of Jahad Daneshgahi, number 146, South Gandi street, Vanak square
City
Tehran
Postal code
15179-64311
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.ACECR.IBCRC.REC.1394.49
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
neuropathy
Timepoint
before satrting intervention and 6-12-24 weeks after that
Method of measurement
NCI-CTCAE and FACT-TAXAN questionnaire
Secondary outcomes
1
Description
quality of life
Timepoint
before starting intervention and in 6-12-24 weeks after that
Method of measurement
FACT-TAXAN questionnaire
Intervention groups
1
Description
intervention group: duloxetine capsule (Duloxicap produced by Tadbir Kala-e Jam pharmaceutical company) taken orally 30 mg daily starting with first dose of Paclitaxel till 2 weeks after last course of Paclitaxe
Category
Treatment - Drugs
2
Description
control group: placebo of duloxetine PO daily starting with first dose of Paclitaxel till 2 weeks after last course of Paclitaxe
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Breast Cancer Clinic of Jahad Daneshgahi
Full name of responsible person
Dr Safa Najafi
Street address
Nazari street, Aboureihan street, Enghelab street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Breast Cancer Research Center of Jahad Daneshgahi
Full name of responsible person
Dr Olfatbakhsh
Street address
number 146, South Gandi street, Vanak square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Breast Cancer Research Center of Jahad Daneshgahi
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Tadbir Kalay-e Jam Pharmaceutical Company
Full name of responsible person
Dr yousefi
Street address
number 1,Babak markazi alley, Africa street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tadbir Kalay-e Jam Pharmaceutical Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshty University of Medical Sciences
Full name of responsible person
Dr Azin Ahmari
Position
resident of Radiation Oncology
Other areas of specialty/work
Street address
Emam hossein hospital, Shahid madani street
City
Tehran
Postal code
Phone
+98 21 73430
Fax
Email
azin_ahmari@sbmu.ac.irazin_ahmari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshty University of Medical Siences
Full name of responsible person
Dr Ali Ghanbari Motlagh
Position
Radiation Oncologist
Other areas of specialty/work
Street address
Emam Hossein hospital, Shahid madani street
City
Tehran
Postal code
Phone
+98 21 73430
Fax
Email
agmotlagh@sbmu.ac.iragmotlagh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshty University of Medical Siences
Full name of responsible person
Dr Azin Ahmari
Position
resident of Radiation Oncology
Other areas of specialty/work
Street address
Emam Hossein hospital, Shahid madani street
City
Tehran
Postal code
Phone
+98 21 73430
Fax
Email
azin_ahmari@yahoo.comazin_ahmari@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)