The purpose of this study is to evaluate the efficacy of N-acetylcysteine (NAC) in preventing cisplatin-induced ototoxicity in patients receiving cisplatin-based chemotherapy. Cisplatin is a highly effective chemotherapeutic agent but often leads to permanent hearing loss (ototoxicity) as a significant side effect. This study investigates whether the administration of NAC as an otoprotective agent can reduce or prevent the decline in hearing sensitivity, particularly at extended high frequencies, as measured by audiometry and distortion product otoacoustic emissions (DPOAE).
Patients aged between 18 and 70 years
Patients scheduled to receive high-dose cisplatin-based chemotherapy regimens with a projected cumulative cisplatin dose of > 200 mg/m2 and each dose > 50 mg/m2
Patients may receive concurrent chemotherapy with non-ototoxic agents
Patients may receive concurrent radiation therapy to the skull base, provided the radiation dose does not exceed the toxic threshold for ototoxicity
Patients diagnosed with Nasopharyngeal Carcinoma (CA nasopharynx).
Patients with a history of head and neck radiation therapy where the radiation dose to the cochlea exceeded 9 Gy or the dose to the eustachian tube exceeded 50 Gy on both sides.
Patients who have received N-acetylcysteine (NAC) within 2 weeks prior to the start of the study.
Parallel
Acetyl cysteine
DrugN-acetylcysteine at a dosage of 150 mg/kg in 5%DW 200 mL intravenous 4-6 hour after completion of cisplatin which dosage more than 50 mg/m2 and planned cumulative dose more than 200 mg/m2
Normal Saline
DrugNormal saline 200 mL intravenous 4-6 hour after completion of cisplatin which dosage more than 50 mg/m2 and planned cumulative dose more than 200 mg/m2
- Extended high frequency audiogram - DPOAE
Compare hearing levels between the N-Acetylcysteine group and the placebo group in patients receiving cisplatin, at one month after the completion of treatment by audiometry in term of each frequency and Pure tone average of 500,1000,2000 and 500,1000,2000,4000 and DPOAE
- Extended high frequency audiogram - DPOAE
\- Compare hearing levels between the N-Acetylcysteine group and the placebo group in patients receiving cisplatin, prior to each cisplatin cycle administration and 4 months after completion of treatment by audiometry in term of each frequency and Pure tone average of 500,1000,2000 and 500,1000,2000,4000 and DPOAE
The subsequent otologic symptoms following cisplatin therapy
The subsequent otologic symptoms following cisplatin therapy
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