the effect of doluxetine on the treatment of neuropathy induced by paclitaxol in breast cancer patients
Design
This is a double blind clinical trial study. The study population included all patients with breast cancer under treatment with Paclitaxel and have complain of neuropathy. A total of 40 individuals will be randomly assigned into two groups of intervention and control, for which the questionnaire will be completed. Both groups will test EMG-NCV. The intervention group will receive duloxetine capsule. The control group will receive the placebo. Then patients will be re-examined will be performed again.
Settings and conduct
This is a double blind clinical trial study. The study population included all patients with breast cancer and neuropathy under treatment Paclitaxel who attend to the hospital. A total of 40 individuals will be randomly assigned into two groups. Patients will be blind to their allocation into intervention and control groups.The physician investigator who offers the intervention and also a physician in physics will be blinded to groups allocation into intervention and control.
Participants/Inclusion and exclusion criteria
Persons over 18 years of age, Good co-operation, Patients with breast cancer under the first course of paclitaxel therapy, People under the age of 75
Intervention groups
The intervention group included 20 patients with breast cancer who were treated with paclitaxel. Patients were initially treated with duloxetine capsules. In the control group, patients will be treated with placebo containing starch similar in form and color of duloxetine.
Main outcome variables
Neuropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180805040700N1
Registration date:2018-12-06, 1397/09/15
Registration timing:registered_while_recruiting
Last update:2018-12-06, 1397/09/15
Update count:0
Registration date
2018-12-06, 1397/09/15
Registrant information
Name
Marziyeh Hesam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 3145
Email address
m.hesam@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Doluxetine On The Treatment Of Neuropathy Induced By Paclitaxol In Breast Cancer Patients
Public title
The Effect Of Doluxetine On The Treatment Of Neuropathy Induced By Paclitaxol In Breast Cancer Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Persons over 18 years of age
Good co-operation
Patients with breast cancer under the first course of paclitaxel therapy
People under the age of 75
Exclusion criteria:
intolerance of duloxetine
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
sample allocation into the control and intervention group will be done using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind:
1.Patients will be blind to their allocation into intervention and control groups.
2. The physician investigator who offers the intervention and also a physician in physics who perform the assessment by EMG-NCV test for the patients will be blinded to groups allocation into intervention and control.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of َArak University of Medical Sciences
Street address
amir al momenin Hospital
City
arak
Province
Markazi
Postal code
3848176941
Approval date
2018-01-21, 1396/11/01
Ethics committee reference number
IR.ARAKMU.REC.1396.270
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
first referral of patients and 12 weeks after start intervention
Method of measurement
Patient Neurotoxicity Questionnaire = PNQ, EMG-NCV of the four limbs Amplitude and latency analysis of mental and movement neurals of lower and lower fever
Secondary outcomes
empty
Intervention groups
1
Description
Control group: in the control group , patients treated with placebo, prepared by the pharmacist, will be examined in terms of their shape and color and the same size as doluxetine and containing Strachan.
Category
Placebo
2
Description
Intervention group: We treat patients by 30 milligram Doluxetine in first week and we treat 60 milligram in 11 week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Marzie Hesam
Street address
Ayatollah Khansari Teaching Hospital.Daneshgah street
City
Aarak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5002
Email
head_khansari@arakmu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmandzadegan
Street address
Ayatollah Khansari Teaching Hospital
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5003
Email
Head_khansari@arakmu.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Position
Vice-Chancellor for Research of Arak University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Ayatollah Khansari Hospital
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5003
Email
Arjomandzadegan@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Marziyeh Hesam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Arak. Alam alhoda Ave.` Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
38186494
Phone
+98 86 3313 3145
Fax
Email
m.hesam@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Marziyeh Hesam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ayatollah khansari hospital
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3313 3145
Fax
Email
m.hesam@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
no
When the data will become available and for how long
no
To whom data/document is available
no
Under which criteria data/document could be used
no
From where data/document is obtainable
no
What processes are involved for a request to access data/document