Hearing Loss After Radiotherapy/Chemotherapy
Conditions
Interventions
Patient group with Hearing Loss Following Radiotherapy/Chemotherapy:None
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed with head and neck cancer, scheduled to receive radiotherapy and/or chemotherapy (RT/CT) or combined modality treatment (RT+CT); 2. Age >=18 years (adults) or >=1 year (children, with guardian’s informed consent); 3. Expected survival >=2 years, without severe organ dysfunction (ECOG score <=2); 4. Normal baseline hearing before treatment (pure-tone average threshold <=25 dB HL) or presence of tumor-related hearing loss; 5. Signed informed consent, with provision of peripheral blood samples for whole-exome sequencing (WES) and genotyping (e.g., TPMT, SOD2);
Exclusion criteria
Exclusion criteria: 1. Previous history of radiotherapy or chemotherapy (including targeted therapy) for head and neck cancer; 2. History or current presence of non-oncological ear diseases, including but not limited to: chronic ear infections, cholesteatoma, Ménière's disease, otosclerosis, noise trauma, autoimmune hearing loss, radiation-induced hearing loss, syphilitic deafness, endolymphatic hydrops, hearing loss due to otologic surgery, suspected retrocochlear lesions (e.g., vestibular schwannoma), suspected perilymph fistula or membrane rupture, perilymph fistula or barotrauma, pulsatile tinnitus (potentially indicative of glomus jugulare tumor), or abnormalities of the skull, face, or temporal bone; 3. Concurrent history of using other ototoxic medications (e.g., aminoglycoside antibiotics, loop diuretics); 4. Family history of hereditary hearing loss; 5. Pregnant or lactating women; 6. Inability to comply with follow-up (e.g., residing in a remote area, high risk of loss to follow-up, significant cognitive impairment, or inability to complete hearing tests); 7. Other reasons deemed by the investigator as making the participant unsuitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pure Tone Audiometry (PTA);Otoscopy outcome;Tympanometry? ;Genetic testing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging test;Hearing-Related Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactLi Wenyan; Wang Xiaoshen
Eye & ENT Hospital of Fudan University
Outcome results
None listed