Aims: The aim of the present study was to examine whether preconditioning with normobaric hyperoxia would prevent cisplatin-induced nephrotoxicity in patients with solid tumor.
Methods: Twenty-one adult patients with solid tumor treated with cisplatin were entered in this pilot and prospective study between Feb 2009 and Nov 2009.
Inclusion criteria: the patients who treated with cisplatin due to cancer.
Exclusion criteria: The patients who had chronic obstructive lung disease, pneumothorax, upper respiratory infection, fever, viral infection, history of seizure, pregnancy, optic nerve inflammation, history of ear surgery and history of heavy cigarette smoking were excluded from this study.
Ten patients were exposed to pure oxygen via non-rebreathing reservoir mask which increased the provided oxygen rate to 60% oxygen for 2 hours at 48, 24 and 6 hours before intravenous administration of cisplatin. Venous blood samples were obtained from all patients for serum urea and creatinine (Cr) measurements as primary outcome on day 1 before and days 2 and 5 days after cisplatin exposures. The renal function was also measured with the glomerular filtration rate (GFR) estimated by the Cockcroft-Gault equation [GFR = (140-age) × (Wt in kg) × (0.85 if female) / (72 × Cr)].
Docetaxel (trade name Taxotere) was given 75 mg/m2 intravenous on day 1; consequently cisplatin was administered 50 mg/m2 at the second day and 2-3 L of normal saline was infused on the day of cisplatin administration. All patients received 5-FU 350 mg/m2 for five days after injection of cisplatin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102065775N1
Registration date:2011-04-10, 1390/01/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-10, 1390/01/21
Registrant information
Name
behzad Einollahi
Name of organization / entity
Baqiyatallah
Country
Iran (Islamic Republic of)
Phone
+98 88037667
Email address
einollahi@ijnu.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2009-02-01, 1387/11/13
Expected recruitment end date
2009-11-01, 1388/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Normobaric hyperoxia preconditioning ameliorates cisplatin nephrotoxicity: a pilot prospective case-control study
Public title
Normobaric hyperoxia preconditioning ameliorates cisplatin nephrotoxicity: a pilot prospective case-control study
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the patients who treated with cisplatin due to cancer
Exclusion criteria: The patients who had chronic obstructive lung disease, pneumothorax, upper respiratory infection, fever, viral infection, history of seizure, optic nerve inflammation, history of ear surgery and history of heavy cigarette smoking were excluded from this study. None of female patients was pregnant.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
21
Randomization (investigator's opinion)
Randomized
Randomization description
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 Baqiyatallah University
Street address
Baqiyatallah Hospital
City
Tehran
Postal code
Approval date
2008-06-02, 1387/03/13
Ethics committee reference number
13873/29---س/340/22
Health conditions studied
1
Description of health condition studied
Acute renal failure
ICD-10 code
N17
ICD-10 code description
Acute renal failure
Primary outcomes
1
Description
Serum Creatinine
Timepoint
0, 6,24,48
Method of measurement
Serum creatinine measurment previous day and 6, 24, 48 houre after Hyperoxia preconditioning
Secondary outcomes
1
Description
eGFR decrementation
Timepoint
-1, 0, 2, 5 days after threatment
Method of measurement
plasma creatinine for GFR estimation in all patients in-1, 0, 2 and 5 days after cisplatin exposures.
Intervention groups
1
Description
pure oxygen 60% via non-rebreathing reservoir mask for 2 hours at 48, 24 and 6 hours before intravenous administration of cisplatin.
Category
Prevention
2
Description
Docetaxel (trade name Taxotere) was given 75 mg/m2 intravenous on day 1
Category
Prevention
3
Description
2-3 Liter of normal saline intravenous on the day of cisplatin administration during 4-6 hours
Category
Prevention
4
Description
cisplatin 50 mg/m2 at the second day intravenous
Category
Treatment - Drugs
5
Description
5-FU 350 mg/m2 intravenous for five days after injection of cisplatin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Behzad Einollahi
Street address
Ground Floor of Baqiyatallah Hospital, Baqiyatallah Medical University, Mollasdra Ave., Vanak Squ., Tehran, Iran; Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology and Urology Research Center, Baqiyatallah 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
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Behzad Einollahi
Position
Professor of Nephrology
Other areas of specialty/work
Street address
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8126 2073
Fax
Email
einollahi@ijnu.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Behzad Einollahi
Position
Professor of Nephrology
Other areas of specialty/work
Street address
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8126 2073
Fax
Email
einollahi@ijnu.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Behzad Einollahi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)