NCT04226456

Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity

Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.

Detailed description

This is a monocentric, randomized, controlled, open label phase IV superiority trial. After signing the informed consent form and upon the confirmation of the patient eligibility, patients will be randomized 1:1 to the experimental arm (NAC + Cisplatin) or the standard arm (Cisplatin). The primary objective of this trial is to evaluate the protecting effect of Lysomucil® 10% against Cisplatin-induced ototoxicity. In this case, we will evaluate its effect through the transtympanic administration in both ears.

Conditions

• Ototoxic Hearing Loss
• Ototoxic Hearing Loss, Bilateral
• Ototoxicity
• Tinnitus

Interventions

Type	Name	Description
DRUG	N-acetyl cysteine	Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears

Timeline

• Start date: 2021-07-10
• Primary completion: 2023-05-03
• Completion: 2023-09-03
• First posted: 2020-01-13
• Last updated: 2023-10-24

Locations

1 site across 1 country: Belgium