Platinum-based chemotherapy-induced hearing loss
Conditions
Interventions
Observation group (Platinum- induced hearing):N/A
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Subjects voluntarily participate in the clinical trial, sign the informed consent form (ICF) with a documented date, demonstrate understanding of the trial content, procedures, and potential adverse reactions, and agree to comply with the study protocol; (2) Aged >=6 years and= 1 year; (8) Eastern Cooperative Oncology Group (ECOG) performance status 0–1; (9) Pre-treatment peripheral blood routine meets the following criteria: neutrophil count > 2000/mm³; platelet count > 100,000/mm³; (10) Pre-treatment liver and renal function meets the following criteria: bilirubin 60 ml/min.
Exclusion criteria
Exclusion criteria: (1) Presence of implants in the study ear at screening (e.g., cochlear implant, artificial ossicle, tympanostomy tube, etc.); (2) Patients with oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer, or ocular tumors with non-squamous cell carcinoma pathological type; (3) No use of platinum-based chemotherapy, or concurrent use of platinum-based chemotherapy with other ototoxic chemotherapeutic agents (e.g., vincristine, cyclophosphamide, bleomycin, fluorouracil, etc.); (4) Patients with cochlear radiation dose exceeding 30 Gy; (5) History of head trauma, acute otitis media, or other ear infections within the past 3 months; history of chronic suppurative otitis media, tympanic membrane perforation, conductive hearing loss, mixed hearing loss, ear trauma or ear surgery; concurrent middle ear/inner ear malformation, otosclerosis, Meniere's disease, or sudden sensorineural hearing loss with unimproved hearing—conditions that may interfere with result interpretation; (6) History of ototoxic drug use or occupational noise exposure; (7) Abnormal tympanometry (Type B or C); (8) History of exposure to harmful substances (e.g., organic solvents, heavy metals); (9) Family history of hereditary deafness or congenital deafness; (10) Previous anti-tumor radiotherapy or chemotherapy that may cause hearing loss; (11) Positive pregnancy test at screening or baseline; pregnant or lactating women, or women planning to become pregnant during the trial; (12) Concurrent diseases or conditions that may affect eligibility or safety during the study; (13) Active mental disorders or other psychological conditions impairing the ability to sign the informed consent form or understand the study; (14) Uncontrolled active infection; (15) Any conditions deemed unsuitable for study participation by joint evaluation of radiation oncologists and otolaryngologists; inability to participate due to personal reasons; or behaviors that may interfere with treatment, study conduct, or result interpretation (e.g., previous high-dose aminoglycoside therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demographic characteristics;Pure tone audiometry;Tympanometry test;Speech audiometry; | — |
Countries
China
Contacts
Public ContactYilai Shu
Eye & ENT Hospital of Fudan University
Outcome results
None listed