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Evaluation of the efficacy of duloxetine and venlafaxine in chemotherapy-induced neuropathy in cancer patients,A double-blind clinical trial with placebo

Protocol summary

Study aim
Efficacy of duloxetine and venlafaxine in chemotherapy-induced peripheral neuropathy pain among cancer patients
Design
A receiving duloxetine treatment, group B receiving venlafaxine and group C receiving placebo. People will be randomly selected based on the table of random numbers obtained by a computer program, and based on that, the samples included in the study will be divided into different groups and equalization will be done. This work will continue until we reach a sufficient number of samples in each group.
Settings and conduct
Patients will be collected in Fatemeh Zahra Hospital, 5Azar Hospital, and Sayad Shirazi Hospital in Gorgan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients diagnosed with cancer by pathology sample Exclusion criteria: Inability to confirm chemotherapy-induced neuropathy diagnosis
Intervention groups
Group A patients are treated with 30 mg of duloxetine capsules in the first week and then 30 mg twice a day. In group B, patients are treated with 37.5 mg of venlafaxine in the first week, and then they are treated with 37.5 mg twice a day. In group C, patients were treated with a placebo, which was contained starch.
Main outcome variables
1. Comparison of average BPI score in the group treated with duloxetine, venlafaxine, and placebo at the beginning of treatment, weeks 6 and 12 2. Comparison of the average PNQ score in the group treated with duloxetine, venlafaxine, and placebo at the beginning of treatment, weeks 6 and 12 3. Comparison of average SF36 score in the group treated with duloxetine, venlafaxine and placebo at the beginning of treatment, weeks 6 and 12

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240314061286N1
Registration date: 2024-04-18, 1403/01/30
Registration timing: registered_while_recruiting

Last update: 2024-04-18, 1403/01/30
Update count: 0
Registration date
2024-04-18, 1403/01/30
Registrant information
Name
narges lashkarbolouk
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3255 2060
Email address
nargeslashkarbolouk@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-21, 1403/01/02
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of duloxetine and venlafaxine in chemotherapy-induced neuropathy in cancer patients,A double-blind clinical trial with placebo
Public title
Evaluation of the efficacy of duloxetine and venlafaxine in chemotherapy-induced neuropathy in cancer patients,A double-blind clinical trial with placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years and under 80 years Cancer patients based on the diagnosis of the physician and the pathology sample Willingness and consent to participate in the study Do not use drugs that affect serotonin levels Do not use painkillers and drugs effective on neuropathic pain routinely from two weeks before starting duloxetine or venlafaxine
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 141
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants are divided into three groups: Group A receives duloxetine treatment, Group B receives venlafaxine, and Group C receives a placebo using a random block method. Participants are selected randomly based on a table of random numbers generated by a computer program. A block is chosen from the table, and participants included in the study are assigned to different groups accordingly. This process continues until each group reaches a sufficient number of samples. For instance, if block number 1 is selected in the first round, the first two samples will be assigned to Group A, the third and fourth samples to Group B, and so forth.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicines and placebo are provided to patients in similar envelopes by the pharmacist based on a random table of numbers and without informing the treating physician of their title. At the beginning of the treatment and 6 and 12 weeks after the treatment, the subjects were re-examined with the PNQ questionnaire, the SF36 quality of life questionnaire, and the BPI pain questionnaire. The people who completed the questionnaires did not know the type of medicine. Drug side effects for all groups will be recorded and reported.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Shast kola Ave.
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.GOUMS.REC.1402.510

Health conditions studied

1

Description of health condition studied
Drug-induced polyneuropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy

Primary outcomes

1

Description
Comparison of the average BPI score in the group treated with duloxetine and venlafaxine and placebo
Timepoint
at the beginning of treatment, weeks 6 and 12
Method of measurement
brief pain inventory

2

Description
Comparison of mean SF36 score in the group treated with duloxetine and venlafaxine and placebo
Timepoint
at the beginning of treatment, weeks 6 and 12
Method of measurement
Item short form survey36

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cancer patients treated with chemotherapy will be treated with duloxetine. Group A patient are treated with 30 mg of duloxetine capsules in the first week and then 30 mg twice a day from the second week.
Category
Treatment - Drugs

2

Description
Control group: Cancer patients treated with chemotherapy will be treated with placebo
Category
Placebo

3

Description
Intervention group 2: In group B, patients are treated with 37.5 mg of venlafaxine daily, and from the second week, they are treated with a dose of 37.5 mg twice a day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Mahdi Mazandarani
Street address
Minudasht Ave.
City
Minudasht
Province
Golestan
Postal code
3522340534
Phone
+98 17 3522 3405
Email
Mahdi_mazandarani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Najmeh shahini
Street address
Shast kolla street
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Fax
Email
Info@goums.ac.ir
Grant name
Gorgan Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Najmeh shahini
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
Shast kolla Ave
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0319
Email
Najmeh.shahini@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Najmeh shahini
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
Shast kolla Ave
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0319
Email
Najmeh.shahini@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges Lashkarbolouk
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sayad shirazi hospital
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3255 2060
Fax
Email
nargeslashkarbolouk@goums.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Part of the data, such as information related to the main outcome or similar, can be shared.
When the data will become available and for how long
Since 2024
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
No analyzes are allowed on the delivered data.
From where data/document is obtainable
Dr.Najmeh shahini
What processes are involved for a request to access data/document
No analyzes are allowed on the delivered data.
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