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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
45
Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.
Placebo treatment
Daniel Munoz
Santiago, Santiago Metropolitan, Chile
Hearing threshold
High frequencies pure tone average
Time frame: Baseline.
Hearing threshold
High frequencies pure tone average
Time frame: up to 4th week of chemoradiotherapy
Hearing threshold
High frequencies pure tone average
Time frame: through study completion, an average of 3 months
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