Actively Recruiting
Evaluation of Hidden Hearing Loss and Vestibular Damage Induced by Anti-cancer Treatments
Led by Direction Centrale du Service de Santé des Armées · Updated on 2024-07-08
540
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate hidden hearing loss and vestibular damage caused by cancer treatments in patients and healthy volunteers. It focuses on assessing the ear and balance side effects linked to anticancer drugs, especially platinum-based therapies, radiotherapy, and chemotherapy. The study explores the limitations of current hearing tests and works to identify better diagnostic methods and biomarkers to detect subtle auditory and vestibular damage that affects quality of life and may increase risks such as falls or cognitive decline. Participants will undergo auditory, vestibular, and electrophysiological tests including otoacoustic emissions, electrocochleography, vocal audiometry in noise, and high-frequency tonal audiometry. Blood samples will be taken to analyze seric proteins as potential biomarkers. The study includes different groups: patients previously exposed to ototoxic agents, patients about to start such treatments, and healthy volunteers. Visits occur either once after exposure or multiple times before, during, and after treatment to monitor changes over time. During the study, participants will attend clinic visits every two weeks for checkups and tests. They will complete questionnaires and undergo various hearing and balance assessments without changes to their standard cancer care. Researchers will analyze statistics on audiometry, electrophysiological tests, and protein levels at multiple time points. The study aims to better understand ototoxicity patterns and improve early detection through combined subjective and objective measures, with ongoing monitoring up to nine months after treatment.
CONDITIONS
Brief Title
Diagnostic of Various Ototoxicity Induced by Cancer Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and over
- Registered with social security
- Signed informed consent
- No presbycusis before cancer treatment for groups A and C
- No known presbycusis for group B
- Previous exposure to ototoxic or neurotoxic agents for group A
- Indication to start ototoxic or neurotoxic therapy for group C
You will not qualify if you...
- Subjects deprived of liberty
- Unable to read or write French
- Pregnant or breastfeeding women
- Previous treatment for ototoxicity
- History of bilateral ear diseases such as otosclerosis, perilymphatic fistula, ruptured eardrum, autoimmune hearing loss, acoustic neuroma
- History of severe head trauma with Glasgow Coma Score ≤ 8
- Abnormal otoscopy or tympanometry
- For group B: previous chemotherapy or ENT radiotherapy
- Ongoing ototoxic drug or corticosteroid therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 months depending on group assignment
Participants undergo auditory, vestibular, electrophysiological, and biologic investigations to assess hearing loss and vestibular damage potentially induced by cancer treatments.
Multiple visits including Day 0-Day 2, and follow-ups at Days 7, 14, 21, 180, and 270 for some participants
Trial Site Locations
Total: 1 location
1
HIA Bégin
Paris, France
Actively Recruiting
Research Team
F
François-Régis FERRAND
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
23
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