Overview

This trial is active, not recruiting.

Condition cisplatin nephrotoxicity
Treatments acetazolamide, acetylcysteine, mannitol, saline, cisplatin
Phase phase 2
Sponsor Ain Shams University
Start date November 2013
End date October 2015
Trial size 52 participants
Trial identifier NCT02760901, master

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
mannitol
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
saline
saline hydration 2500 ml before cisplatin therapy
cisplatin
patients with tumours already prescribed cisplatin
(Active Comparator)
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.
acetazolamide ACTZ
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
saline
saline hydration 2500 ml before cisplatin therapy
cisplatin
patients with tumours already prescribed cisplatin
(Active Comparator)
patients received acetylcysteine NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.
acetylcysteine NAC
patients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
saline
saline hydration 2500 ml before cisplatin therapy
cisplatin
patients with tumours already prescribed cisplatin

Primary Outcomes

Measure
Serum Creatinine
time frame: change from baseline after 3 cycles separated by 21 days
Creatinine clearance according to Cockroft-Gault equation
time frame: change from baseline after 3 cycles separated by 21 days
Acute kidney injury
time frame: change from baseline after 3 cycles separated by 21 days
Blood urea nitrogen (BUN)
time frame: change from baseline after 3 cycles separated by 21 days

Secondary Outcomes

Measure
Aspartate Transaminase (AST)
time frame: change from baseline after 3 cycles separated by 21 days
hemoglo bin
time frame: change from baseline after 3 cycles separated by 21 days
adverse events
time frame: change from baseline after 3 cycles separated by 21 days
Alanine Transaminase (ALT)
time frame: change from baseline after 3 cycles separated by 21 days
platelets count
time frame: change from baseline after 3 cycles separated by 21 days
total leucocyte count
time frame: change from baseline after 3 cycles separated by 21 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Ain Shams University.