NCT03400709

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

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Hospital San Juan de Dios, Santiago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cisplatin Adverse Reaction
• Hearing Loss Ototoxic

Interventions

Type	Name	Description
DRUG	N Acetylcysteine	Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.
DRUG	Placebo Oral Tablet	Placebo treatment

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-06-01
• Completion: 2017-11-01
• First posted: 2018-01-17
• Last updated: 2018-01-17

Locations

1 site across 1 country: Chile