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NCT Number: NCT02760901

Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity

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.

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Key information

Conditions

Cisplatin Nephrotoxicity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Acetazolamide

Drug

patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity

Other names: ACTZ

acetylcysteine

Drug

patients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity

Other names: NAC

Mannitol

Drug

patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.

Saline

Drug

saline hydration 2500 ml before cisplatin therapy

Cisplatin

Drug

patients with tumours already prescribed cisplatin

Primary outcomes

  1. Serum Creatinine

    Time frame: change from baseline after 3 cycles separated by 21 days

    Blood samples collected and measured in laboratory with the unit mg/dL

  2. Creatinine clearance according to Cockroft-Gault equation

    Time frame: change from baseline after 3 cycles separated by 21 days

    calculated using globalrph calculators , unit ml/min

  3. Acute kidney injury

    Time frame: change from baseline after 3 cycles separated by 21 days

    Acute kidney injury assessed by RIFLE criteria that was calculated for patients

  4. Blood urea nitrogen (BUN)

    Time frame: change from baseline after 3 cycles separated by 21 days

    Blood samples collected and measured in laboratory with the unit mg/dl

Secondary outcomes

  1. Aspartate Transaminase (AST)

    Time frame: change from baseline after 3 cycles separated by 21 days

    Liver function tests were monitored by measuring AST for change from baseline after 3 cycles separated by 21 days

  2. hemoglo bin

    Time frame: change from baseline after 3 cycles separated by 21 days

    hemoglobin concentration g/dl was monitored for change from baseline after 3 cycles separated by 21 days

  3. adverse events

    Time frame: change from baseline after 3 cycles separated by 21 days

    Monitoring adverse events: to evaluate the difference between three groups regarding frequency of adverse events.

  4. Alanine Transaminase (ALT)

    Time frame: change from baseline after 3 cycles separated by 21 days

    Liver function tests were monitored by measuring ALT for change from baseline after 3 cycles separated by 21 days

  5. platelets count

    Time frame: change from baseline after 3 cycles separated by 21 days

    platelets count cells per ml was monitored for change from baseline after 3 cycles separated by 21 days

  6. total leucocyte count

    Time frame: change from baseline after 3 cycles separated by 21 days

    total leucocyte count cells per ml was monitored for change from baseline after 3 cycles separated by 21 days

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
May 4, 2016
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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