Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- N Acetylcysteine
- Conditions
- Cisplatin Adverse Reaction
- Sponsor
- Hospital San Juan de Dios, Santiago
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Hearing threshold
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Daniel Munoz MD, MSc.
Otolaryngologist, Clinical Epidemiologist.
Hospital San Juan de Dios, Santiago
Eligibility Criteria
Inclusion Criteria
- •Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin.
Exclusion Criteria
- •Conductive Hearing Loss
- •SNHL with \>= 40db PTA
Arms & Interventions
N-acetylcisteine group
Intervention: N Acetylcysteine
Control group
Intervention: Placebo Oral Tablet
Outcomes
Primary Outcomes
Hearing threshold
Time Frame: through study completion, an average of 3 months
High frequencies pure tone average