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

Centre Hospitalier Universitaire Saint Pierre

Status and phase: Terminated; Phase 4

Conditions: Ototoxic Hearing Loss; Tinnitus; Ototoxic Hearing Loss, Bilateral; Ototoxicity

Treatments: Drug: N-acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT04226456

CHUB-NAC

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Control

No Intervention group

Description:

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.

N-acetylcysteine

Experimental group

Description:

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.

Treatment:

Drug: N-acetyl cysteine