Ototoxic Hearing Loss, Ototoxic Hearing Loss, Bilateral, Ototoxicity, Tinnitus
Conditions
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.
Interventions
DRUGN-acetyl cysteine
Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparition of ototoxicity | 6 month after last injection | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System) | 6 month after last injection | 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). |
| Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA | 6 month after last injection | 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. |
| Hearing quality of life: Tinnitus Handicap Index (THI) | 6 month after last injection | Tinnitus Handicap Index (THI) score Range : 0 to 100. Higher scores mean a worse outcome. |
Countries
Belgium
Outcome results
None listed