Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC) ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans. Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans compared to mannitol and to each other. Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving acetazolamide and 17 patients receiving NAC. Patients' kidney function was monitored using serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed using RIFLE criteria. Patients' liver function tests and hematological parameters were also monitored.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
52
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
patients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
saline hydration 2500 ml before cisplatin therapy
patients with tumours already prescribed cisplatin
Serum Creatinine
Blood samples collected and measured in laboratory with the unit mg/dL
Time frame: change from baseline after 3 cycles separated by 21 days
Creatinine clearance according to Cockroft-Gault equation
calculated using globalrph calculators , unit ml/min
Time frame: change from baseline after 3 cycles separated by 21 days
Acute kidney injury
Acute kidney injury assessed by RIFLE criteria that was calculated for patients
Time frame: change from baseline after 3 cycles separated by 21 days
Blood urea nitrogen (BUN)
Blood samples collected and measured in laboratory with the unit mg/dl
Time frame: change from baseline after 3 cycles separated by 21 days
Aspartate Transaminase (AST)
Liver function tests were monitored by measuring AST for change from baseline after 3 cycles separated by 21 days
Time frame: change from baseline after 3 cycles separated by 21 days
hemoglo bin
hemoglobin concentration g/dl was monitored for change from baseline after 3 cycles separated by 21 days
Time frame: change from baseline after 3 cycles separated by 21 days
adverse events
Monitoring adverse events: to evaluate the difference between three groups regarding frequency of adverse events.
Time frame: change from baseline after 3 cycles separated by 21 days
Alanine Transaminase (ALT)
Liver function tests were monitored by measuring ALT for change from baseline after 3 cycles separated by 21 days
Time frame: change from baseline after 3 cycles separated by 21 days
platelets count
platelets count cells per ml was monitored for change from baseline after 3 cycles separated by 21 days
Time frame: change from baseline after 3 cycles separated by 21 days
total leucocyte count
total leucocyte count cells per ml was monitored for change from baseline after 3 cycles separated by 21 days
Time frame: change from baseline after 3 cycles separated by 21 days
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