Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
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.