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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Treatments: Acetylcysteine; Cisplatin; N-monoacetylcystine

Criteria

Inclusion Criteria:

• ≥ 18-year-old

• Patients suffering from a neoplastic disease for which treatment protocol includes Cisplatin.

Exclusion Criteria:

• Women of childbearing potential pregnant or with intention to become pregnant within the trial duration

• Pathological findings on otoscopy that do not allow safe intratympanic drug delivery and reliable distortion product otoacoustic emissions (DPOAEs) testing.

• Conductive hearing loss > 10 decibel hearing level (dBHL)

• Meniere disease

• Medical history of sudden hearing loss

• Sensorineural Hearing loss (SNHL) with mean ≥ 40dbHL Pure Tonal Audiometry (PTA)