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Diagnostic of Various Ototoxicity Induced by Cancer Treatment

Key facts

Who runs it
Direction Centrale du Service de Santé des Armées
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
540 people, planned
Started
19 Jun 2024
Expected to end
19 Sept 2027
Type of study
Observational, 23 groups
Treatments tested
  • Auditory, vestibular and electrophysiological investigations
  • Biologic investigations; seric proteins
Record updated
8 July 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Previous treatment for ototoxicity
  • Previous chemotherapy
  • Previous ENT radiotherapy
  • Ongoing ototoxic drug therapy (quinine, diuretics, aminoglycosides, aspirin, NSAIDs) or corticosteroid therapy
  • 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)
  • - Subjects deprived of liberty
  • Subjects unable to read or write the French language
  • Pregnant and breast-feeding women
  • Abnormal otoscopy or tympanometry In addition for group B

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

• 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).

Read full original descriptionShow less

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 23 groups in the trial

  • A:Previously exposed to CISPLATIN with significant ATL damage

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to CISPLATIN without significant ATL damage

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to cochlear RADIOTHERAPY with significant ATL damage

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to cochlear RADIOTHERAPY WITHOUT significant ATL damage

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN with significant ATL damage

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN WITHOUT significant ATL damage

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to OXALIPLATIN

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to CARBOPLATIN

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to TAXANES

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to VINCALCALOIDS

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Previously exposed to other neurotoxicant

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • B:Patients cured of cancer without ototoxic or neurotoxic exposure

    Groupe B

    Treatment: Auditory, vestibular and electrophysiological investigations

  • B:Companions without ototoxic or neurotoxic exposure

    Groupe B

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Hyperacusic patients following cancer treatment

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Tinnitus patients following cancer treatment

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • A:Patients with vestibular disorders following cancer treatment

    Groupe A

    Treatment: Auditory, vestibular and electrophysiological investigations

  • C:Patients with an indication for CISPLATIN recruited prior to any treatment

    Groupe C

    Treatment: Auditory, vestibular and electrophysiological investigations and Biologic investigations; seric proteins

  • C:Patients indicated for cochlear radiotherapy and recruited prior to treatmen

    Groupe C

    Treatment: Auditory, vestibular and electrophysiological investigations and Biologic investigations; seric proteins

  • C:Patients with indication for CISPLATIN and cochlear radiotherapy recruited prior any treatment

    Groupe C

    Treatment: Auditory, vestibular and electrophysiological investigations and Biologic investigations; seric proteins

  • C:Patients with an indication for OXALIPLATIN treatment recruited prior to any treatment

    Groupe C

    Treatment: Auditory, vestibular and electrophysiological investigations and Biologic investigations; seric proteins

  • C:Patients with indication for CARBOPLATIN recruited prior to any treatment

    Groupe C

    Treatment: Auditory, vestibular and electrophysiological investigations and Biologic investigations; seric proteins

  • C:Patients with indication for TAXANES therapy recruited prior to any treatment

    Groupe C

    Treatment: Auditory, vestibular and electrophysiological investigations and Biologic investigations; seric proteins

  • C:Patients with indication for VINCALCALOIDES or other neurotoxicant

    Groupe C

    Treatment: Auditory, vestibular and electrophysiological investigations and Biologic investigations; seric proteins

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Hidden Hearing Loss and Vestibular Damage Induced by Anti-cancer Treatments
Record updated
8 July 2024