Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer
- Conditions
- Cisplatin Adverse ReactionHearing Loss Ototoxic
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03400709
- Lead Sponsor
- Hospital San Juan de Dios, Santiago
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin.
- Conductive Hearing Loss
- SNHL with >= 40db PTA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description N-acetylcisteine group N Acetylcysteine - Control group Placebo Oral Tablet -
- Primary Outcome Measures
Name Time Method Hearing threshold through study completion, an average of 3 months High frequencies pure tone average
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Daniel Munoz
🇨🇱Santiago, Metropolitana, Chile