Evaluation of Hidden Hearing Loss and Vestibular Damage Induced by Anti-cancer Treatments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 540
- Locations
- 1
- Primary Endpoint
- Descriptive statistics for electrophysiological tests of the various groups
Study Overview
Brief Summary
• 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)
Detailed Description
Ototoxicity refers to all the auditory and vestibular consequences of a mechanical, radiological and/or chemical aggressor, which can affect these functions via common or specific mechanisms.
Quantification of auditory damage (whatever the type of aggressor) is currently mainly assessed by pure tone audiometry (TTA). However, apart from its subjectivity, LTA only takes into account the audibility of auditory signals - most often only the frequencies of the speech spectrum - and not an individual's ability to analyze and interpret these signals. From an objective point of view, apart from acoustic otoemissions, which have revolutionized neonatal hypoacusis screening, ototoxicity assessment suffers from the absence of reliable biomarkers, objective witnesses of a lesion more or less specific to the type of aggression.
Patients undergoing treatment for cancer are exposed to numerous iatrogenic risks that potentially impact quality of life, whether in a curative or palliative context. In terms of ototoxicity to anticancer drugs (mainly platinum salts), less than half of patients benefit from follow-up during and after exposure to these treatments, despite existing recommendations for cisplatin. There are no recommendations for other anti-cancer drugs (including other platinum salts and neurotoxic drugs) in the absence of clear evidence of a reduction in ATL scores, but the analysis of the literature shows above all a lack of screening for other forms of ototoxicity. Yet the potential consequences of failing to treat hypoacusis can be dramatic: a strong statistical link has been demonstrated, notably with the risk of dementia and mortality, which could also be impacted by the increased risk of falls caused by impaired balance due to vestibulotoxicity (the investigation of which is exceptional in the absence of a vertigo attack).
Areas for improvement include prevention recommendations, improved accessibility to audiometric monitoring, and the development of robust, time-saving diagnostic tests (in patients who often present with other iatrogenic or cancer-induced problems) - the main focus of our study - and the identification of effective treatments.
Vocal noise audiometry (VNA) is an ideal candidate for describing hearing impairment in cancer patients, because :
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Descriptive statistics for electrophysiological tests of the various groups
Time Frame: 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
Time Frame: 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)
Descriptive statistics for audiometry of the various groups
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported