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临床试验/NCT06490029
NCT06490029招募中不适用

Evaluation of Hidden Hearing Loss and Vestibular Damage Induced by Anti-cancer Treatments

Direction Centrale du Service de Santé des Armées1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2024年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
540
试验地点
1
主要终点
Descriptive statistics for electrophysiological tests of the various groups

研究概览

简要总结

• 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)

详细描述

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 :

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • - 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

结局指标

主要结局

Descriptive statistics for electrophysiological tests of the various groups

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

研究点 (1)

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