Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
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.