• 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Age 18 and over
* Registered with social security
* Signed consents
* Absence of presbycusis prior to cancer treatment (groups A and C)
* No known presbycusis (group B)
* Previous exposure to an ototoxic/neurotoxic agent (group A)
* Indication for initiation of ototoxic/neurotoxic therapy (group C)
Exclusion Criteria:
* \- Subjects deprived of liberty
* Subjects unable to read or write the French language
* Pregnant and breast-feeding women
* Previous treatment for ototoxicity
* History of bilateral auditory pathology, in particular otosclerosis, perilymphatic fistula, ruptured tympanic membrane, autoimmune hearing loss, acoustic neuroma.
* History of severe head trauma (Glasgow Coma Score \<= 8)
* Abnormal otoscopy or tympanometry In addition for group B
* Previous chemotherapy
* Previous ENT radiotherapy
* Ongoing ototoxic drug therapy (quinine, diuretics, aminoglycosides, aspirin, NSAIDs) or corticosteroid therapy
Primary outcome measure(s)
Descriptive statistics for audiometry of the various groups — Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C) Percentage of correct consonant identification as a function of signal-to-noise ratio for speech audiometry in noise
Descriptive statistics for electrophysiological tests of the various groups — Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C) amplitudes of the acoustic distortion products collected during the measurement of induced acoustic otoemissions
Descriptive statistics for protein analyses of the various groups — Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C) Concentration of selected proteins in plasma (/mL)
Trial sites (1)
Facility
City
Region
Status
HIA Bégin
Paris
France
Recruiting
More Direction Centrale du Service de Santé des Armées trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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