drugset / Trial / NCT03400709

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer

NCT03400709

Completed 45 enrolled Hospital San Juan de Dios, Santiago
RandomizedParallel-groupSingle-blindPrevention

Summary

Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.

Timeline

Start
2015-11
Primary completion
2017-06
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule Oral