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

Phase 4TerminatedNCT04226456

Centre Hospitalier Universitaire Saint Pierre19 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Ototoxic Hearing Loss Ototoxic Hearing Loss, Bilateral Ototoxicity Tinnitus

Interventions

N-acetyl cysteineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

CHU Saint-Pierre

Brussels, Belgium

Outcomes

Primary Outcomes

Apparition of ototoxicity

the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5: * A Threshold shift of 15 - 25 decibel (dB) averaged at 2 contiguous test frequencies in at least one ear * and/or the apparition of a tinnitus (not previously present).

Time frame: 6 month after last injection

Secondary Outcomes

Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System)

the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5: * A Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear * and/or the apparition of a tinnitus (not previously present).

Time frame: 6 month after last injection

Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA

Evaluation of the Impact of Hearing Loss in Adults (ERSA) For each question, the score of 0 means maximal difficulties, the sore of 10 means ideal situation Formulation is uniform, with no inversions: 0 always corresponds to maximal difficulty and 10 to an ideal situation, so that the lower the score the greater the impact of hearing loss on quality of life. Maximum score is 200 for respondents in work and 150 for those not in work or in retirement.

Time frame: 6 month after last injection

Hearing quality of life: Tinnitus Handicap Index (THI)

Tinnitus Handicap Index (THI) score Range : 0 to 100. Higher scores mean a worse outcome.

Time frame: 6 month after last injection

Data from ClinicalTrials.gov

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