Clinical trial NCT02760901: Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity
Official title: Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cisplatin Nephrotoxicity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Cancer patients to receive cisplatin based chemotherapy protocol.
2. Adult patients from 18 to 65 years.

Exclusion Criteria:

1. Existing renal impairment ( Creatinine clearance \<30 ml/minute)
2. Severe hepatic impairment (Child Pugh score C).
3. Hypersensitivity to sulfonamides.
4. Patients with chronic non-congestive angle closure glaucoma.
5. Hypersensitivity to sulphur compounds, N-acetylcysteine or any component of the formulation.

Primary outcomes:
measure: Serum Creatinine
timeFrame: change from baseline after 3 cycles separated by 21 days
measure: Creatinine clearance according to Cockroft-Gault equation
timeFrame: change from baseline after 3 cycles separated by 21 days
measure: Acute kidney injury
timeFrame: change from baseline after 3 cycles separated by 21 days
measure: Blood urea nitrogen (BUN)
timeFrame: change from baseline after 3 cycles separated by 21 days
Secondary outcomes:
measure: Aspartate Transaminase (AST)
timeFrame: change from baseline after 3 cycles separated by 21 days
measure: hemoglo bin
timeFrame: change from baseline after 3 cycles separated by 21 days
measure: adverse events
timeFrame: change from baseline after 3 cycles separated by 21 days
measure: Alanine Transaminase (ALT)
timeFrame: change from baseline after 3 cycles separated by 21 days
measure: platelets count
timeFrame: change from baseline after 3 cycles separated by 21 days
measure: total leucocyte count
timeFrame: change from baseline after 3 cycles separated by 21 days
Other outcomes:
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