Investigating and comparing the therapeutic effect of Nevazin and vitamin B1 in chemotherapy-induced neuropathy in cancer patients undergoing chemotherapy
Determining the therapeutic effect of Nevazin and vitamin B1 in chemotherapy-induced neuropathy
Design
A clinical trial with a control group, with parallel groups, randomized, phase 3, 27 samples in each group. Allocation of samples to intervention groups is done using random blocks method with blocks of size 6
Settings and conduct
In present study cancer patients with neuropathy symptoms are selected from the chemotherapy department of Qazvin Velayat hospital. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All cancer patients who are undergoing chemotherapy and have neuropathy.
Exclusion criteria: use of other drugs effective in improving neuropathy such as Gabapentin, Pregavalin, Duloxetine.
Intervention groups
Intervention Group: Daily prescription of one 150 mg Nevazin tablet produced by Pars Gita Daru Company for three months.
Control Group: Daily prescription of one 150 mg Vitamin B1 tablet produced by Razak Company for three months.
Main outcome variables
Severity of neuropathy after chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230722058878N1
Registration date:2023-09-04, 1402/06/13
Registration timing:prospective
Last update:2023-09-04, 1402/06/13
Update count:0
Registration date
2023-09-04, 1402/06/13
Registrant information
Name
Seyyed Aboozar Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
aboozar.mousavi28@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-21, 1402/06/30
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the therapeutic effect of Nevazin and vitamin B1 in chemotherapy-induced neuropathy in cancer patients undergoing chemotherapy
Public title
The effect of Nevazin and vitamin B1 in treatment of chemotherapy-induced neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All cancer patients who are undergoing chemotherapy
Exclusion criteria:
People who are allergic to medicines containing vitamin B
use of other drugs effective in improving neuropathy such as Gabapentin, Pregavalin, Duloxetine
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two treatment groups A and B using the method of random blocks (Balance block randomization), the size of each block is 6 and the total number of blocks is 9. Sealedenvelope.com will be used to implement block 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 Qazvin University of Medical Sciences
Street address
Research and Technology deputy, Mavaddat Alley, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2023-08-30, 1402/06/08
Ethics committee reference number
IR.QUMS.REC.1402.140
Health conditions studied
1
Description of health condition studied
neuropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy
2
Description of health condition studied
chemotherapy
ICD-10 code
Z51.11
ICD-10 code description
Encounter for antineoplastic chemotherapy
Primary outcomes
1
Description
Severity of neuropathy after chemotherapy
Timepoint
Before and after treatment
Method of measurement
Valk questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Daily prescription of one 150 mg Nevazin tablet produced by Pars Gita Daru Company for three months
Category
Treatment - Drugs
2
Description
Control group: Daily prescription of one 150 mg Vitamin B1 tablet produced by Razak Company for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Seyyed Aboozar Mousavi
Street address
22 Bahman Blvd., Minoodar region
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
aboozar.mousavi28@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Seyyed Aboozar Mousavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahoner Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
aboozar.mousavi28@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Aboozar Mousavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
University campus building, Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
aboozar.mousavi28@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Aboozar Mousavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
University campus building, Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
aboozar.mousavi28@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