Assessing hearing loss caused by cancer treatments
Evaluation of Hidden Hearing Loss and Vestibular Damage Induced by Anti-cancer Treatments
This study is testing how certain cancer treatments might affect hearing and balance in cancer patients and healthy volunteers by doing regular hearing tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Direction Centrale du Service de Santé des Armées Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT06490029 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the ototoxic effects of anticancer drugs on patients through systematic hearing tests, including auditory functional assessments, vestibular tests, and biological investigations. Participants will undergo checkups every two weeks, either before, during, or after exposure to potential ototoxic agents. The study will include cancer patients treated with various modalities and healthy volunteers to better understand the impact of these treatments on hearing and balance. The goal is to identify hidden hearing loss and vestibular issues that may not be detected by standard assessments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over who are undergoing treatment for cancer and have no prior history of presbycusis or significant auditory pathology.
Not a fit: Patients with a history of severe head trauma, previous treatment for ototoxicity, or those currently receiving ototoxic drug therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for detecting ototoxicity in cancer patients, enhancing their quality of life.
How similar studies have performed: While there is limited evidence on the specific methodologies used in this study, previous research has indicated the importance of monitoring ototoxicity in cancer patients, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- HIA Bégin — Paris, France (Recruiting)
Study contacts
- Study coordinator: François-Régis FERRAND
- Email: francois-regis.ferrand@def.gouv.fr
- Phone: 0178651249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.