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

NCT ID: NCT04226456

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-10
• Study Completion Date: 2023-09-03

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

N-acetylcysteine

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.

Group Type: EXPERIMENTAL

N-acetyl cysteine

Intervention Type: DRUG

Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears

Interventions

N-acetyl cysteine

Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears

Intervention Type: DRUG

Other Intervention Names

Lysomucil 10%

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaëtan Cavelier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Saint Pierre

Locations

CHU Saint-Pierre

Brussels, , Belgium

Countries

Belgium

Other Identifiers

CHUB-NAC

Identifier Type: -

Identifier Source: org_study_id