A Phase 4 interventional study of N-acetyl cysteine in Ototoxic Hearing Loss, Ototoxic Hearing Loss, Bilateral and Ototoxicity, sponsored by Centre Hospitalier Universitaire Saint Pierre. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by Centre Hospitalier Universitaire Saint Pierre · Phase 4, Interventional, and Prevention
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.
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's enrollment of 19 is below the median of 47 across 33 interventional studies indexed under Ototoxicity.
Browse Ototoxicity studies →Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard arm (Arm A): Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease) Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease.
Experimental arm (Arm B): * 0.4 to 1 ml of NAC 10% through intratympanic injection (ITI) from 40 to 60 minutes maximum prior to each Cisplatin cycle. * Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease) Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease.
Drug: N-acetyl cysteine
Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears
Also known as: Lysomucil 10%
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
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
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Acetylcysteine
Centre Hospitalier Universitaire Saint Pierre