Diagnostic of Various Ototoxicity Induced by Cancer Treatment
ConditionOtotoxicity, Drug-Induced
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDirection Centrale du Service de Santé des Armées
About this trial
• Visit the clinic once every 2 weeks for checkups and tests The goal of this clinical trial is to learn if systematic hearing tests (eg fonctional assesment, electrophysiology and seric biomarkers) can diagnose hidden hearing loss or vestibular troubles in a population of patients treated for cancer; population study will include different population in terms of sex/gender, age, medical condition (cancer patients treated with surgery alone and/or radiotherapy and/or chemotherapy, and healthy volunteers).
The main question it aims to answer is:
• To assess the ototoxicity of anticancer drugs using a combination of auditory functional tests (including speech audiometry in noise), vestibular test , plasmatic samples and electrophysiological measures.
Participants will be studied:
Either only after exposition (single visit) Or before, during and after the exposition to potential otototoxic agents with a 4 times Visit the clinic checkups and tests (one before, two while ongoing potential ototoxic agents and 1 post exposition)
Participants will complete questionnaires, undergo audiometric and electrophysiological tests, and their routine biomedical data will be studied, without any modification of the routine care (planned cancer treatment)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 and over
Registered with social security
Signed consents
Absence of presbycusis prior to cancer treatment (groups A and C)
Disqualifiers
- Subjects deprived of liberty
Subjects unable to read or write the French language
Pregnant and breast-feeding women
Previous treatment for ototoxicity
Trial population
patients treated, not treated or to be treated for cancer or hematologic recquiring neurotoxic treatment
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Auditory, vestibular and electrophysiological investigations
Diagnostic testotoacoustic emissions, electrocochleography, vocal audiometry in noise and high-frequency tonal audiometry, impedancemetry
Biologic investigations; seric proteins
Diagnostic testseric proteins
Treatment groups
540 Participants
are divided into 23 treatment groups23
Treatment groupsSee each treatment group below.
Group A: A:Previously exposed to CISPLATIN with significant ATL damage1 intervention
Group B: A:Previously exposed to CISPLATIN without significant ATL damage1 intervention
Group C: A:Previously exposed to cochlear RADIOTHERAPY with significant ATL damage1 intervention
Group D: A:Previously exposed to cochlear RADIOTHERAPY WITHOUT significant ATL damage1 intervention
Group E: A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN with significant ATL damage1 intervention
Group F: A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN WITHOUT significant ATL damage1 intervention
Group G: A:Previously exposed to OXALIPLATIN1 intervention
Group H: A:Previously exposed to CARBOPLATIN1 intervention
Group I: A:Previously exposed to TAXANES1 intervention
Group J: A:Previously exposed to VINCALCALOIDS1 intervention
Group K: A:Previously exposed to other neurotoxicant1 intervention
Group L: B:Patients cured of cancer without ototoxic or neurotoxic exposure1 intervention
Group M: B:Companions without ototoxic or neurotoxic exposure1 intervention
Group N: A:Hyperacusic patients following cancer treatment1 intervention
Group O: A:Tinnitus patients following cancer treatment1 intervention
Group P: A:Patients with vestibular disorders following cancer treatment1 intervention
Group Q: C:Patients with an indication for CISPLATIN recruited prior to any treatment2 interventions
Group R: C:Patients indicated for cochlear radiotherapy and recruited prior to treatmen2 interventions
Group S: C:Patients with indication for CISPLATIN and cochlear radiotherapy recruited prior any treatment2 interventions
Group T: C:Patients with an indication for OXALIPLATIN treatment recruited prior to any treatment2 interventions
Group U: C:Patients with indication for CARBOPLATIN recruited prior to any treatment2 interventions
Group V: C:Patients with indication for TAXANES therapy recruited prior to any treatment2 interventions
Group W: C:Patients with indication for VINCALCALOIDES or other neurotoxicant2 interventions
Trial outcomes
Primary outcomes
1
Descriptive statistics for audiometry of the various groups
Percentage of correct consonant identification as a function of signal-to-noise ratio for speech audiometry in noise
Time frame
Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C)2
Descriptive statistics for electrophysiological tests of the various groups
amplitudes of the acoustic distortion products collected during the measurement of induced acoustic otoemissions
Time frame
Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C)3
Descriptive statistics for protein analyses of the various groups
Concentration of selected proteins in plasma (/mL)
Time frame
Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C)Sponsors and contacts
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Source ClinicalTrials.gov