Effect of the N-acetyl cysteine versus placebo on prevention and control of chemotherapy induced neuropathy in patients with breast cancer: a triple-blind randomized clinical trial
To assess the effect of the N-acetyl cysteine versus placebo on prevention and control of chemotherapy induced neuropathy in patients with breast cancer
Design
This is a triple-blind randomized clinical trial, phase II, in which 102 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with breast cancer referring to the Imam Khomeini Clinic in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be triple-blinded so that neither patients nor the physician examining the patients and statistical analyzer will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range: 18 to 80 years old; be candidate for chemotherapy.
Exclusion criteria: history of neuropathy with grade greater than one; behavioral disorders; history of chemotherapy; history of asthma.
Intervention groups
Intervention group: tablet N-acetyl cysteine (manufactured by Darman Yab Daru Pharmaceutical Co.) 1200 mg twice daily one day before chemotherapy with Taxane until one day after that.
Control group: tablet placebo (manufactured by School of Pharmacy, Shahid Beheshti University of Medical Science) twice daily one day before chemotherapy with Taxane until one day after that.
Main outcome variables
Severity of neuropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N377
Registration date:2021-01-25, 1399/11/06
Registration timing:prospective
Last update:2021-01-25, 1399/11/06
Update count:0
Registration date
2021-01-25, 1399/11/06
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the N-acetyl cysteine versus placebo on prevention and control of chemotherapy induced neuropathy in patients with breast cancer: a triple-blind randomized clinical trial
Public title
Effect of the N-acetyl cysteine versus placebo on prevention and control of chemotherapy induced neuropathy in patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18 to 80 years old
Candidate for chemotherapy
Exclusion criteria:
History of neuropathy with grade greater than one
Behavioral disorders
History of chemotherapy
History of asthma
Age
From 18 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The care provider who will deliver the medications and the physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Thus, the trial will be run as triple-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.UMSHA.REC.1399.534
Health conditions studied
1
Description of health condition studied
Neuropathy
ICD-10 code
G60.3
ICD-10 code description
Idiopathic progressive neuropathy
Primary outcomes
1
Description
Severity of neuropathy
Timepoint
Before chemotherapy and three weeks after that
Method of measurement
Using the NCI-CTCAE v4.0 scale and Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: tablet N-acetyl cysteine (manufactured by Darman Yab Daru Pharmaceutical Co.) 1200 mg twice daily one day before chemotherapy with Taxane untile one day after that
Category
Treatment - Drugs
2
Description
Control group: tablet placebo (manufactured by School of Pharmacy, Shahid Beheshti University of Medical Science) twice daily one day before chemotherapy with Taxane until one day after that
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Clinic in Hamadan city
Full name of responsible person
Elyas Hassanzade
Street address
Imam Khomeini Clinic, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3832 1371
Email
elyas.hassanzade@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Elyas Hassanzade
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
elyas.hassanzade@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Abdolazim Sedighi Pashaki
Position
Radiotherapist
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
a.sedighipashaki@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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