Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer… (NCT06297369) | Clinical Trial Compass
UnknownPhase 2
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Egypt60 participantsStarted 2024-02-01
Plain-language summary
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Exposu…
What they're measuring
1
The occurrence of cisplatin-induced ototoxicity in the form of hearing loss.
Timeframe: 4 cycles of cisplatin (at base line and each cycle range from 21-28 days and or fractionated)