An observational study in Ototoxicity, Drug-Induced, sponsored by Direction Centrale du Service de Santé des Armées. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Direction Centrale du Service de Santé des Armées · Observational
The main question it aims to answer is:
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)
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 :
However, the various reference techniques used to assess AVB differ in complexity (comprehension of sentences, syllables, dissyllabic words or logatomes), normative value, conditions and duration, making analysis of intelligibility functions all the more complex. It is generally accepted that logatomes enable us to test the periphery of the auditory system, whereas words and sentences involve mental substitution and the subject's semantic knowledge, and therefore enable us to test hearing in conditions closer to those encountered in everyday life.
In a population particularly exposed to the risk of fatigue and cognitive disorders (chemo-induced cognitive disorders), it is therefore necessary to carry out a study incorporating quality of life questionnaires to take these associated factors into account. In addition, depending on the treatment (and its intensity) and cancer location, different compartments of the auditory system may be affected by the risk of ototoxicity, requiring objective tests (at least on part of our study population) to assess the vestibule, inner ear - in particular to differentiate ciliopathy from cochlear synaptopathy - and middle ear, in order to clarify their respective involvement in functional loss.
The investigators propose to study these parameters in several patient populations, exposed - or not - to ototoxic and/or neurotoxic agents. Comparison within and between these different populations will enable us to assess the specificity and sensitivity of the subjective and objective tests proposed in this study, as well as the validity of composite biomarkers constructed from results on specific groups.
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's planned enrollment of 540 is above the median of 111 across 14 observational studies indexed under Ototoxicity.
Browse Ototoxicity studies →Direction Centrale du Service de Santé des Armées is the lead sponsor of 95 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients treated, not treated or to be treated for cancer or hematologic recquiring neurotoxic treatment
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe B
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe B
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe A
Diagnostic Test: Auditory, vestibular and electrophysiological investigations
Groupe C
Diagnostic Test: Auditory, vestibular and electrophysiological investigations · Diagnostic Test: Biologic investigations; seric proteins
Groupe C
Diagnostic Test: Auditory, vestibular and electrophysiological investigations · Diagnostic Test: Biologic investigations; seric proteins
Groupe C
Diagnostic Test: Auditory, vestibular and electrophysiological investigations · Diagnostic Test: Biologic investigations; seric proteins
Groupe C
Diagnostic Test: Auditory, vestibular and electrophysiological investigations · Diagnostic Test: Biologic investigations; seric proteins
Groupe C
Diagnostic Test: Auditory, vestibular and electrophysiological investigations · Diagnostic Test: Biologic investigations; seric proteins
Groupe C
Diagnostic Test: Auditory, vestibular and electrophysiological investigations · Diagnostic Test: Biologic investigations; seric proteins
Groupe C
Diagnostic Test: Auditory, vestibular and electrophysiological investigations · Diagnostic Test: Biologic investigations; seric proteins
otoacoustic emissions, electrocochleography, vocal audiometry in noise and high-frequency tonal audiometry, impedancemetry
seric proteins
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)
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)
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)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Mar 2025, 9 months after the start.
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Direction Centrale du Service de Santé des Armées