Ototoxicity MedDRA version: 20.0 Level: PT Classification code 10033109 Term: Ototoxicity System Organ Class: 10013993 - Ear and labyrinth disorders
Conditions
Interventions
Trade Name: Lysomucil®
Product Name: Lysomucil
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ACETYLCYSTEINE
Current Sponsor code: ACETYLCYSTEINE
Concentration unit: % percent
Concen
Sponsors
CHU Saint Pierre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - = 18-year-old - Patients suffering from a neoplasic disease for which treatment protocol includes Cisplatin. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: - Women of childbearing potential pregnant or with intention to become pregnant within the trial duration NOTE: Women of childbearing potential should use adequate birth control measures, as defined by the investigator. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include: - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) - Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) - Intrauterine device (IUD) - Intrauterine hormone-releasing system (IUS) - Bilateral tubal occlusion - Vasectomized partner - Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient) - Women who are breastfeeding - Pathological findings on otoscopy that do not allow safe intratympanic drug delivery and reliable distortion product otoacoustic emissions (DPOAEs) testing. - 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 |
|---|---|
| Main Objective: 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. ;Secondary Objective: The secondary objectives include: - Evaluate the effect of the treatment on patients’quality of life. - Evaluate the impact of the treatment on the risk of discontinuation of the Cisplatin chemotherapy when an ototoxicity occurs. ;Primary end point(s): Primary endpoint is 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). ;Timepoint(s) of evaluation of this end point: - A Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear = 6 months after the last administration of treatment. - and/or the apparition of a tinnitus (not previously present) = 6 months after the last administration of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System) - Quality of life (Evaluation of the Impact of Hearing Loss in Adults (ERSA), Tinnitus Handicap Index (THI));Timepoint(s) of evaluation of this end point: - Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System) = 6 months after the last administration of treatment. - Quality of life (Evaluation of the Impact of Hearing Loss in Adults (ERSA), Tinnitus Handicap Index (THI)) = 6 months after the last administration of treatment. | — |
Countries
Belgium
Contacts
Public ContactGaëtan Cavelier
CHU Saint Pierre
Outcome results
None listed