Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
Ototoxic Hearing Loss, Ototoxic Hearing Loss, Bilateral, Ototoxicity
About this trial
This is an interventional prevention trial for Ototoxic Hearing Loss
Eligibility 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
- Women who are breastfeeding
- Pathological findings on otoscopy that do not allow safe intratympanic drug delivery.
- Conductive hearing loss > 20dBHL
- Meniere disease
- Medical history of sudden hearing loss
- Sensoryneural Hearing loss (SNHL) with mean ≥ 40dbHL Pure Tonal Audiometry (PTA)
Sites / Locations
- CHU Saint-Pierre
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
N-acetylcysteine
Standard arm (Arm A): Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease) Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease.
Experimental arm (Arm B): 0.4 to 1 ml of NAC 10% through intratympanic injection (ITI) from 40 to 60 minutes maximum prior to each Cisplatin cycle. Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease) Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease.