An interventional study of N Acetylcysteine and Placebo Oral Tablet in Cisplatin Adverse Reaction and Hearing Loss Ototoxic, sponsored by Hospital San Juan de Dios, Santiago. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Hospital San Juan de Dios, Santiago · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Drug: N Acetylcysteine
Drug: Placebo Oral Tablet
Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.
Placebo treatment
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
Plan to share: No
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Hospital San Juan de Dios, Santiago