Using N-acetylcysteine to prevent side effects from cisplatin in cancer patients
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
This study is testing if N-acetylcysteine can help cancer patients avoid harmful side effects from cisplatin chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06297369 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of N-acetylcysteine (NAC) in preventing toxicities associated with cisplatin chemotherapy in cancer patients. Cisplatin is a widely used anticancer drug known for its efficacy but also for causing significant side effects such as nephrotoxicity, neurotoxicity, and ototoxicity. The study aims to determine if NAC can mitigate these adverse reactions by acting as an antioxidant and restoring the balance of pro-oxidants and antioxidants in the body. Eligible participants include cancer patients over 18 years old who are set to receive cisplatin treatment at specific dosages.
Who should consider this trial
Good fit: Ideal candidates are cancer patients aged over 18 who are scheduled to receive cisplatin-containing chemotherapy.
Not a fit: Patients with preexisting peripheral neuropathy or significant hearing loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the harmful side effects of cisplatin, improving the quality of life for cancer patients undergoing treatment.
How similar studies have performed: Previous studies have shown promise in using NAC to reduce chemotherapy-induced injuries, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt. — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: mahmoud ibrahim — Ain Shams University
- Study coordinator: mahmoud ibrahim, master
- Email: mahmoudibrahim9797@gmail.com
- Phone: 01067803525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.