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

Tinnitus Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04226456
Study type Interventional
Source Centre Hospitalier Universitaire Saint Pierre
Contact
Status Terminated
Phase Phase 4
Start date July 10, 2021
Completion date September 3, 2023
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