Determining the Effectiveness of Venlafaxine and Duloxetine in Improving chronic neurotoxicity induced by Chemotherapy in Cancer Patients
Design
The Admitted patients Were divided into two groups of 15 people based on Balanced Balance Randomization. The first group was treated with venlafaxine and the second group was treated with duloxetine.
Settings and conduct
Oncology Department Of Rasoul Akram Hospital
Participants/Inclusion and exclusion criteria
Condition for Entering the Study: Age 18 to 75 Years, Incidence of Neuropathy after Starting Chemotherapy, Cancer Diagnosis, Receive Chemotherapy; Non_Entry Condition: Having an Underlying Neuropathy Disease Such as Diabetes Mellitus, Incomplete Treatment, Intolerance of The Patient due to Drug Side Effects, Death of Patients
Intervention groups
Cancer Patients Undergoing Chemotherapy Regimen as Outpatient or Inpatient
Main outcome variables
Sex, Age, Treatment Group, Peripheral Neuropathy, Severity of Neuropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230201057300N1
Registration date:2023-02-15, 1401/11/26
Registration timing:retrospective
Last update:2023-02-15, 1401/11/26
Update count:0
Registration date
2023-02-15, 1401/11/26
Registrant information
Name
Hanzaleh Jourebrahimiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5422 8717
Email address
h.jourebrahimian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-14, 1397/01/25
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
2018-04-17, 1397/01/28
Actual recruitment end date
2019-04-13, 1398/01/24
Trial completion date
2019-04-13, 1398/01/24
Scientific title
Comparison of the Efficacy of Venlafaxine and Duloxetine in Improving Chemotherapy-Induced Neurotoxicity in Cancer Patients
Public title
The Efficacy of Venlafaxine and Duloxetine in Improving Chemotherapy-Induced Neurotoxicity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75 years
Incidence of Neuropathy after starting Chemotherapy
Cancer Diagnosis
Receive Chemotherapy
Exclusion criteria:
Having an Underlying Neuropathy Disease such as Diabetes Mellitus
Incomplete Treatment
Intolerance of the patient due to Drug side effects
Death of Patients
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced Balance Randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medicsl Sciences
Street address
No. 77, Shahid kismoradi Ave., Shahid Shiroudi Blvd., Tonekabon Town
City
Tonekabon
Province
Mazandaran
Postal code
4681947170
Approval date
2017-05-28, 1396/03/07
Ethics committee reference number
Ir. IUMS. FMD. rec. 1397.305
Health conditions studied
1
Description of health condition studied
Chemotherapy-Induced Peripheral Neuropathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of Peripheral Neuropathy
Timepoint
Severity of Peripheral Neuropathy at the Beginning of the study then weekly
Method of measurement
NCI- Common Terminology Criteria for Adverse Event- ver3
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The First Group Was Treated With Venlafaxine at 37.5 mg Daily and Increased to 75 mg if The Patient Tolerated. The Second Group Was Treated With Duloxetine at 30 mg Daily and Increased to 60 mg Daily. The Treatment Will Last Up to 10 Weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Farshid Fardad
Street address
No. 77, Shahid kiamoradi Ave., Shaid Shiroudi Blvd., Tonekabon Town
City
Tonekabon
Province
Mazandaran
Postal code
4681947170
Phone
+98 11 5422 8717
Email
h.jourebrahimian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farshid Fardad
Street address
No. 77, Shahid Kiamoradi Ave., Shahid Shiroudi Blvd., Tonekabon Town
City
Tonekabon
Province
Mazandaran
Postal code
4681947170
Phone
+98 11 5422 8717
Email
h.jourebrahimian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farshid Fardad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
No. 77, Shahid kiamoradi Ave., Shahid Shiroudi Blvd., Tonekabon Town
City
Tonekabon
Province
Mazandaran
Postal code
4681947170
Phone
+98 11 5422 8717
Email
drfardadf@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farshid Fardad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
No. 77, Shahid kiamoradi Blvd., Shahid Shiroudi Blvd., Tonekabon Town
City
Tonekabon
Province
Mazandaran
Postal code
4681947170
Phone
+98 11 5422 8717
Email
drfardadf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hanzaleh Jourebrahimiyan
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 77, Shahid Kiamoradi Ave., Shahid Shiroudi Blvd., Tonekabon Town
City
Tonekabon
Province
Mazandaran
Postal code
4681947170
Phone
+98 11 5422 8717
Email
h.jourebrahimian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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