drugset / Trial / NCT02094625

NAC to Prevent Cisplatin-induced Hearing Loss

NCT02094625

Phase 1 Completed 52 enrolled Children's Hospital Los Angeles
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Cisplatin is a key chemotherapy agent for the treatment of multiple childhood cancers but causes permanent hearing loss. This study investigates the drug N-acetylcysteine (NAC) to determine the dose necessary to protect hearing and also how well tolerated NAC is when combined with chemotherapy.

Timeline

Start
2016-03
Primary completion
2020-09
Completion
2021-08

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 225 mg/kg Intravenous
Subject N-acetylcysteine Small molecule 300 mg/kg Intravenous
Subject N-acetylcysteine Small molecule 375 mg/kg Intravenous
Subject N-acetylcysteine Small molecule 450 mg/kg Intravenous