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Clinical trial

Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity

ID
Name
CHUB-NAC
Description
The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.
Trial arms
Trial start
2021-07-10
Estimated PCD
2023-05-03
Trial end
2023-09-03
Status
Terminated
Phase
Early phase I
Treatment
N-acetyl cysteine
Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears
Arms:
N-acetylcysteine
Other names:
Lysomucil 10%
Size
19
Primary endpoint
Apparition of ototoxicity
6 month after last injection
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2023-10-24

1 organization

1 product

4 indications

Organization
Centre Hospitalier Universitaire Saint Pierre
Product
N-acetyl cysteine
Indication
Ototoxic Hearing Loss
Indication
Bilateral
Indication
Ototoxicity
Indication
Tinnitus