TerminatedPhase 4

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

Stopped: poor recruitment

Belgium19 participantsStarted 2021-07-10

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Apparition of ototoxicity

Timeframe: 6 month after last injection

Trial details

NCT IDNCT04226456

SponsorCentre Hospitalier Universitaire Saint Pierre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-03

View on ClinicalTrials.gov More Ototoxic Hearing Loss trials