This study will be done with Comparative investigation aim effectiveness of Venlafaxine and Duloxetine on peripheral neuropathy caused by chemotherapy. This study is a double-blind clinical trial. The study population will be included all patients with cancer and with peripheral neuropathy with neuropathic complaints referred to oncology clinic of Imam Reza Hospital in Kermanshah. A total of 156 persons will be selected and randomly assigned to experimental and control groups (two experimental groups, a control group). The questionnaire will be provided to the patients in all three groups. In the experimental group Venlafaxine and duloxetine will placed in coded containers with the lid closed and a container containing the drug will be delivered to the patient. The drug will be available within 1 month of consumption and and how to use will be explained to the patient. The use of venlafaxine (37.5 mg capsules every 24 hours) and for duloxetine (capsules of 30 mg every 24 hours) is determined. The control group will receive placebo and one month after taking the drug, the questionnaire will be provided to the patients in all three groups and peripheral neuropathy will be checked beginning of the study, every two weeks and end of the study.
Inclusion criteria were: No uncontrolled blood pressure, diabetes, addiction.
Exclusion criteria: Patients treated with tamoxifen; Incidence of intolerable side effects; No on time and correct use of medicines; No patient cooperation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060922632N1
Registration date:2016-05-23, 1395/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-23, 1395/03/03
Registrant information
Name
Negin Farshchian
Name of organization / entity
Kermanshah University of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 83 3823 2124
Email address
farshchian.n@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2016-06-14, 1395/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study of effectiveness of Venlafaxine and Duloxetine on peripheral neuropathy caused by chemotherapy
Public title
effectiveness of Venlafaxine and Duloxetine on peripheral neuropathy caused by chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were: Patients with cancer and with peripheral neuropathy caused by chemotherapy; Patient written consent; No uncontrolled blood pressure, diabetes, addiction.
Exclusion criteria: Patients treated with tamoxifen; Incidence of intolerable side effects; No on time and correct use of medicines; No patient cooperation
Age
From 15 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
156
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
kums.rec.1394.433
Health conditions studied
1
Description of health condition studied
pripheral neuropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy
Primary outcomes
1
Description
Severity of neuropathy
Timepoint
The first, second week and end of the study (fourth week)
Method of measurement
Based on the visual analogue scale (VAS), Sheehan Disability Scale, Brief Pain Inventory, Depression Inventory (Mood), Beck Depression Inventory (BD1-11), Clinical Global Impression Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1 will receive Venlafaxine capsules 37.5 mg every 24 hours for a month
Category
Treatment - Drugs
2
Description
Control group will receive placebo every24 hours for a month
Category
Placebo
3
Description
Intervention group 2 will receive duloxetine capsules 30 mg every 24 hours for a month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Avisa Alavi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
Avisa Alavi
Position
Medical student
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
avisa_l@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Negin Farshchian
Position
Oncologists
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
negin10860@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Avisa Alavi
Position
Medical Student
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
avisa_l@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)