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

Launched by AIN SHAMS UNIVERSITY · Feb 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called N-acetylcysteine to see if it can help prevent side effects caused by a chemotherapy drug called cisplatin in patients with cancer. Cisplatin can sometimes lead to serious problems like kidney damage, nerve pain, and hearing loss. The researchers hope that by using N-acetylcysteine, they can protect patients from these harmful effects while they undergo treatment.

To participate in this trial, you need to be a cancer patient over 18 years old who will be receiving cisplatin as part of your chemotherapy. You should not have a history of kidney problems, certain types of nerve damage, or severe hearing loss. If you join the study, you will receive N-acetylcysteine alongside your chemotherapy, and the researchers will monitor your health to see how well it works. This trial is currently recruiting participants, and both men and women of various cancer types are welcome to apply.

Gender

ALL

Eligibility criteria

• 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.