Cisplatin is one of the most useful cytotoxic drugs in the treatment of cancers but it s clinical use is associated with nephrotoxicity. In the present study, we investigated the preventive effect of selenium in cisplatin induced nephrotoxicity.
Eighty patients who were candidates to receive cisplatin for chemotherapy, randomly divided into two groups. The first group received selenium 400 microgram 24 hours before cisplatin infusion. The second group recived placebo with the same mode. Serum Creatinine was measured before and the 5th day of cisplatin infusion. Acute renal failure was the main outcome of our study defined as an increase in serum Creatinine more than 0.5 mg/dl. After data collection we compared the incidence of acute renal failure in these two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901213678N1
Registration date:2010-02-20, 1388/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-20, 1388/12/01
Registrant information
Name
Abazar Parsi
Name of organization / entity
Jundishapor Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3013
Email address
dr_abazar_parsi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Ahvaz Jundishapur university of medical sciences
Expected recruitment start date
2010-02-20, 1388/12/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double blind clinical trial for study of preventive effect of selenium in cisplatin induced nephrotoxicity
Public title
Study of preventive effect of selenium in cisplatin induced nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients who were referred to Shafa hospital for chemotherapy with Cisplatin1388-1389
Exclusion criteria:1) serum Creatinine more than 1.5mg/dl in man and more than 1.4mg/dl
in woman
2) Use of other nephrotoxic drug such as NSAID, ACEI, Aminoglycoside
at 2 weeks later
3) Sepsis
4) Pancytopenia
5) Patient who refused Selenium
Age
From 18 years old to 149 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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 Ahvaz Jundishapur university of medical sciences
Street address
Ahvaz Jundishapur university of medical sciences
City
Ahvaz
Postal code
Approval date
2010-03-06, 1388/12/15
Ethics committee reference number
/8/20//5039
Health conditions studied
1
Description of health condition studied
Acute renal failure due to Cisplatin
ICD-10 code
N14
ICD-10 code description
Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions
Primary outcomes
1
Description
Serum creatinine changes
Timepoint
Before and the 5th day after cisplatin infusion
Method of measurement
Enzyme assay
Secondary outcomes
empty
Intervention groups
1
Description
Use of placebo in control group at first day of admission
Category
Placebo
2
Description
Use of selenium (400 microgram) at the first day of admission
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Ahvaz Jundishapur university of medical sciences
Full name of responsible person
Dr Ali Ghorbani
Street address
Intenal medicine ward, Golestan hospital
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Ahvaz Jundishapur 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
Ahvaz jundishapur university of medical sciences
Full name of responsible person
Dr Abazar Parsi
Position
Internal medicine resident
Other areas of specialty/work
Street address
Internal medicine ward, Golestan hospital
City
Ahvaz
Postal code
Phone
+98 61 1374 3013
Fax
Email
dr_abazar_parsi@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz jundishapur university of medical sciences
Full name of responsible person
Dr Ali Ghorbani
Position
Assistant professor of nephrology
Other areas of specialty/work
Street address
Nephrology ward, Golestan hospital
City
Ahvaz
Postal code
Phone
+98 61 1374 3013
Fax
Email
ghorbani-md@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)