Objective: Evaluation the effect of Vitamin E in prevention of Cisplatin-induced Nephrotoxicity. Design: Randomized, double-blind, placebo controlled clinical trial. Setting: Patients with cancer who were treated with cisplatin based chemotherapy regimen at Seyed-Al-Shohada Hospital affiliated to Isfahan University of Medical Sciences. Major Inclusion and Exclusion criteria: Patients aging ≥ 18 years and having glomerular filtration rate (GFR) > 80 ml/min will be enrolled in the study. Patients with comorbidity that affected renal function (such as diabetes mellitus, hypertension, and past history of renal dysfunction), previous chemotherapy, and treatment with other supplementation will be excluded. Intervention: Eligible patients will be randomized to drug and placebo groups. Patients in drug group will be received Vitamin E, 400Iu daily for 21 days starting before cisplatin treatment for 4 cycles. Main outcome measures: Changes in serum creatinine and the GFR compared with baseline value in each cycle after cisplatin treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701011497N5
Registration date:2017-01-15, 1395/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-15, 1395/10/26
Registrant information
Name
Sarah Mousavi
Name of organization / entity
Clinical Pharmacy Department, Pharmacy Faculty, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2567
Email address
smousavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of Vitamin E on cisplatin-induced nephrotoxicity in cancer patients treated with cisplatin-based chemotherapy
Public title
Evaluation the effect of Vitamin E in prevention of cisplatin renal injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were age ≥ 18 years old and having glomerular filtration rate (GFR) > 80 ml/min.
Exclusion criteria were comorbidity that affected renal function (such as diabetes mellitus, hypertension, and past history of renal dysfunction); previous chemotherapy and treatment with other supplementation.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR Iran, 81746 73461
City
Isfahan
Postal code
81746 73461
Approval date
2014-12-20, 1393/09/29
Ethics committee reference number
3514/9/D
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
Changes in serum creatinine and the glomerular filtration rate
Timepoint
From cycle 1 to 4
Method of measurement
laboratory
Secondary outcomes
1
Description
changes in neutrophil gelatinase-associated lipocalin (NGAL) levels
Timepoint
From cycle 1 to 4
Method of measurement
Elisa kit
Intervention groups
1
Description
Patients in drug group will be received Vitamin E (Zahravi Pharmaceutical company, Tabriz, Iran), 400Iu daily for 21 days starting before cisplatin treatment for 4 cycles
Category
Treatment - Drugs
2
Description
Patients in control group will be received placebo of Vitamin E (Zahravi Pharmaceutical company, Tabriz, Iran), 400Iu daily for 21 days starting before cisplatin treatment for 4 cycles
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed-Al-Shohada Hospital
Full name of responsible person
Sarah Mousavi
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Seyed-Al-Shohada Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Grant name
1333/9/12/پ
Grant code / Reference number
393870
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research,Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr Sarah Mousavi
Position
PhD
Other areas of specialty/work
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 7072
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Sarah Mousavi
Position
PhD
Other areas of specialty/work
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 7072
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Sarah Mousavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
73461-81746
Phone
+98 31 3792 7072
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address
mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)