Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490029
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-19
Brief Title:
Diagnostic of Various Ototoxicity Induced by Cancer Treatment
Sponsor:
Direction Centrale du Service de Santé des Armées
Organization:
Direction Centrale du Service de Santé des Armées
Study Overview
Official Title:
Evaluation of Hidden Hearing Loss and Vestibular Damage Induced by Anti-cancer Treatments
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIO-OTOTOX
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 sexgender age medical condition cancer patients treated with surgery alone andor radiotherapy andor 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
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 andor 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 individuals 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
Difficulty understanding speech in noise is one of the first signs of hearing loss in the case of peripheral disorders such as presbycusis linked to ageing or central auditory disorders making it possible to account for ototoxicity linked to different mechanisms or damage to different compartments of the auditory system
AVB allows assessment under more ecological conditions ie closer to situations encountered in everyday life than those of tone or voice audiometry in silence and in a less restrictive way in terms of time taken to perform the test and not requiring access to an audiometric booth
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 subjects 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 andor 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
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 individuals 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
Difficulty understanding speech in noise is one of the first signs of hearing loss in the case of peripheral disorders such as presbycusis linked to ageing or central auditory disorders making it possible to account for ototoxicity linked to different mechanisms or damage to different compartments of the auditory system
AVB allows assessment under more ecological conditions ie closer to situations encountered in everyday life than those of tone or voice audiometry in silence and in a less restrictive way in terms of time taken to perform the test and not requiring access to an audiometric booth
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 subjects 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None