Comparative study of the effect of 25 mg zinc tablets with placebo on the rate of prevention of acute peripheral neuropathy in cancer patients treated with taxanes
Determining the effect of 25 mg zinc capsule with placebo on the prevention of acute peripheral neuropathy in cancer patients treated with taxans
Design
A clinical trial with two intervention groups, in parallel groups, double-blind, randomized with a simple method, with sample size 60
Settings and conduct
At the beginning of the study, all patients of Isfahan Hematology Clinics will be taught about how to conduct the study and the form of conscious satisfaction will be completed by the patients. Then, the demographic information of the patients, the information about the type and stage of the patient's cancer and the diet and the dose of the patient's chemotherapy, as well as the information about the patient's neuropathy score at the beginning of the study will be recorded. In order to randomly select patients in two groups, a numbered number was provided for each patient (from 1 to 152) and the blocking and stratification methods for random distribution of patients based on their number in the intervention groups and We use placebo.
The patient is referred to the hospital every 3 weeks for 3 months (3 follow-up sessions) and then, based on the Criteria for side effects (CTCAE) version 5.0, the degree of neuropathy is examined and evaluated and all information will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cancer confirmed by biopsy and candidate for chemotherapy containing taxan; Be able to give informed consent; The patient's performance status should be such that he or she can describe the condition; Exclusion criteria: They have diabetes, neurological disorders or neuropathy
Intervention groups
We have two intervention groups. One group received placebo and the other group received zinc capsules.
Main outcome variables
neuropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200422047166N1
Registration date:2020-06-10, 1399/03/21
Registration timing:registered_while_recruiting
Last update:2020-06-10, 1399/03/21
Update count:0
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
Farshad Fardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 1072
Email address
farshadfardani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-25, 1399/03/05
Expected recruitment end date
2020-11-25, 1399/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of 25 mg zinc tablets with placebo on the rate of prevention of acute peripheral neuropathy in cancer patients treated with taxanes
Public title
Effect of zinc tablets in the prevention of acute peripheral neuropathy in cancer patients treated with taxanes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cancer confirmed by biopsy and candidate for chemotherapy containing taxan
Be able to give informed consent.
The patient's performance status should be such that he or she can describe the condition.
Exclusion criteria:
They have diabetes, neurological disorders or neuropathy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The study sample is randomly selected and then randomly assigned to the intervention and control group using individual and pair blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Envelopes will be given to patients at random. The patient then delivers the envelope to the drug distributor, where the patient code is recorded. It should be noted that the patient will not be aware of the nature of their medication (medication or placebo) and the physician collecting the study information (internal medicine assistant) will not know the patient's code (the study is two-course).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar Jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.MUI.MED.REC.1398.613
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
Severity of neuropathy
Timepoint
Every 3 weeks for 3 months
Method of measurement
Criteria for side effects table
2
Description
Acute neuropathy
Timepoint
Every 3 weeks for 3 months
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients in the control group receive placebo capsule (25 mg) daily for two hours after lunch for 12 weeks.
Category
Placebo
2
Description
Intervention group: Patients in the intervention group receive 25 mg of zinc sulfate capsule (Alhavi Pharma) daily for two hours after lunch for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology clinics
Full name of responsible person
Ali Haji Gholami
Street address
Isfahan hematology clinics
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3303 3680
Email
Alihajigholami@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Haji Gholami
Position
Assistant Professor of Hematology & Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Al-Zahra Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 913 369 2567
Email
Alihajigholami@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Haji Gholami
Position
Assistant Professor of Hematology & Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Al-Zahra Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 913 369 2567
Email
Alihajigholami@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Haji Gholami
Position
Assistant Professor of Hematology & Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Al-Zahra Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 913 369 2567
Email
Alihajigholami@med.mui.ac.ir
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