NCT07364747

Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Siriraj Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This study is designed as a randomized, double-blind, controlled\] trial to investigate the protective effects of N-acetylcysteine (NAC) against cisplatin-induced hearing loss. Patients scheduled to receive cisplatin chemotherapy will be enrolled. The primary objective is to compare the changes in hearing thresholds between the intervention group (receiving NAC) and the control group. Hearing function will be comprehensively evaluated using: Pure-tone Audiometry (including Extended High-Frequency Audiometry). Distortion Product Otoacoustic Emissions (DPOAE) to assess outer hair cell function. Evaluations will be conducted at baseline (before chemotherapy) and before every cycle of cisplatin administration and 1 month and 4 month after completion . Statistical analysis will include descriptive statistics and comparative tests (such as Unpaired T-tests or Generalized Estimating Equations) to determine the significance of hearing threshold shifts. The study aims to provide evidence on the feasibility and effectiveness of NAC in preserving auditory function in cancer patients. Outcome Measures Primary Outcome Measure: \- 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 Secondary Outcome Measure: * 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

Conditions

• Cisplatin-induced Ototoxicity
• Sensorineural Hearing Loss
• Ototoxicity
• Ototoxicity, Drug-Induced

Interventions

Type	Name	Description
DRUG	Acetyl cysteine	N-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
DRUG	Normal Saline	Normal 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

Timeline

• Start date: 2024-12-23
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Thailand