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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Centre Hospitalier Universitaire Saint Pierre
Updated on 19 February 2021

Summary

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.

Details
Condition Tinnitus, Tinnitus, Ototoxicity, Ototoxic Hearing Loss, ringing in the ears, Ototoxic Hearing Loss, Bilateral, Ototoxic Hearing Loss, Bilateral
Treatment N-Acetyl Cysteine
Clinical Study IdentifierNCT04226456
SponsorCentre Hospitalier Universitaire Saint Pierre
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-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
Pathological findings on otoscopy that do not allow safe intratympanic drug delivery and reliable distortion product otoacoustic emissions (DPOAEs) testing
Conductive hearing loss > 10 decibel hearing level (dBHL)
Meniere disease
Medical history of sudden hearing loss
Sensorineural Hearing loss (SNHL) with mean 40dbHL Pure Tonal Audiometry (PTA)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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