drugset / Trial / NCT07364747

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

NCT07364747

Phase 2 Recruiting 40 enrolled Siriraj Hospital
RandomizedParallel-groupQuadruple-blindPrevention

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).

Timeline

Start
2024-12-23
Primary completion
2026-12-31
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 150 mg/kg Intravenous