Evaluation of the effect of duloxetine on the prevention of neuropathy induced by oxaliplatin
Design
parallel randomized clinical trial consist of placebo and experimental group
Settings and conduct
We enrolled 40 patients who candidate to receive their first course of chemotherapy based on oxaliplatin regimen on Taleghani hospital. They were treated with
duloxetine by increasing the dose from 30 mg/day for first week to 60 mg BD untill 12weeks. Patients’ pain intensity was rated at every course and their quality of life was rated at baseline and 12 weeks
after duloxetine administration.
Participants/Inclusion and exclusion criteria
patients > 18 years old who candidate for their first course of chemotherapy based on oxaliplatin regimen, are included to the study. / patients who have uncontrolled diabetes or hypertension, metastatic stage or using drugs which have significant interaction with duloxetine are not allowed to enter the study.
Intervention groups
Experimental and control group consist of over 18 years old patient who candidate to receive their first course of chemotherapy based on oxaliplatin regimen on Taleghani hospital.
In the patient group, on the first day of the onset of the Oxal platinum chemotherapy regimen, take a 30 mg capsule of duloxetine in the morning, after one week, receive a capsule in the morning and one midday capsule.
In the placebo group, patients received the same capsule of the placebo produced by the same drug company at the first week and from the second week for the first 12 weeks, according to the same method of the test group.
Main outcome variables
neuropathy ( NCI-CTCAE and FACT/GOG-NTX-13 version 14)
quality of life and their emotional state ( FACT-C version 4)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N15
Registration date:2018-06-25, 1397/04/04
Registration timing:registered_while_recruiting
Last update:2018-06-25, 1397/04/04
Update count:0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Duloxetine effect on Oxaliplatin induced peripheral neuropathy prophylaxis
Public title
Evaluation of Duloxetine effect on Oxaliplatin induced peripheral neuropathy prophylaxis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old
The candidate patient is going to get his/her first chemotherapy course with Oxaliplatin drug
Exclusion criteria:
The patient has no uncontrolled diabetes mellitus or uncontrolled hypertension
The patient is not taking drugs which have interaction with Duloxetin
The patient is not on liver metastatic stage
History of duloxetine allergy
hepatic impairment
clcr < 30ml/min and ESRD
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In covariate adaptive randomization, a new participant is sequentially assigned to a particular treatment group by taking into account the specific covariates and previous assignments of participants. in this study covariants factors include : 1.sex 2.age 3.cancer stage. we used Graphpad prism for randomization.
Blinding (investigator's opinion)
Not 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 Shahid Beheshti University of Medical Sciences
Street address
Vali-e-asr ave., Niyayesh junction
City
Tehran
Province
Tehran
Postal code
1991953381
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
IR.SBMU.PHNM.1395.418
Health conditions studied
1
Description of health condition studied
colorectal cancer
ICD-10 code
C18
ICD-10 code description
malignant neoplasm of colon
Primary outcomes
1
Description
peripheral neuropathy
Timepoint
every 2-3 week
Method of measurement
FACT/GOG-NTX-13 and NCI-CTCAE questionaire
Secondary outcomes
1
Description
quality of life
Timepoint
at baseline and 12 weeks later
Method of measurement
FACT-C version 4 questionaire
Intervention groups
1
Description
Intervention group: patient who take duloxetine 30mg/d for first week and then 30 mg BD to 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive one placebo capsule during the first week and then take 2 placebo capsules until 12th week of study.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Rokhsareh soufi
Street address
Arabi St., Yaman St., Chamran highway.,Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 8887 3704
Email
rokhsareh_soufi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli-Ardakani
Street address
Vali-e-asr Ave., Niyayesh junction., Shahid Beheshti pharmacy school
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0085
Email
Mariatavakoli@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rokhsareh Soufi
Position
Pharm D student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e-Asr Ave., Niayesh junction, School of Pharmacy, Shahid Beheshti university of medical sciences
City
Tehran
Province
Tehran
Postal code
1991953381.
Phone
+98 21 8820 0118
Email
rokhsareh_soufi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli-Ardakani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e-asr Ave., Niayesh junction
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
Mariatavakoli@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rokhsareh Soufi
Position
pharm D student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e-asr Ave., Niyayesh junction., Shahid Beheshti pharmacy school
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8887 3704
Email
rokhsareh_soufi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Information are confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available