Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

RHDIRB2020110301 REC #250

Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

2024-02-01

2025-02-01

2025-08-01

Recruiting

Early phase I

60

Inclusion Criteria: * Patients are eligible for inclusion if they meet the following criteria: * Cancer patients aged \>18 years receiving cisplatin-containing chemotherapy. * A cisplatin dose starting from 75 mg/m2. * Various cancer types. * Both males and females. * No history of organ transplantation or kidney dialysis. * Eastern cooperative oncology group performance (ECOG):0-2 Exclusion Criteria: * Patients with peripheral neuropathy. * Preexisting unilateral or bilateral moderate to severe sensorineural hearing loss * Patients with speech discrimination affection or those who are unable to participate in audiologic evaluation * Co-administration of ifosfamide with cisplatin, because of the known risk of nephrotoxicity. * Pregnancy or lactation. * Infection with the human immunodeficiency virus (HIV). * Prior administration of cisplatin. * Intraperitoneal chemotherapy. * Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[ULN\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3 times the upper normal limit \[ULN\] or up to 5.0 upper normal limit \[ULN\] in the presence of hepatic metastases). * Inadequate renal function (creatinine \> 1.25 times upper normal limit \[ULN\], creatinine clearance \< 50mL/min). * Serious comorbid systemic disorder incompatible with the study (uncontrolled diabetes mellitus or hypertension, myocardial infarction within the last 6 months). * Patients diagnosed with kidney cancer. * Exposure to any nephrotoxic drugs or agents.

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2024-03-07