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This observational cohort study was aimed to evaluate the hearing toxicity at multiple time points from baseline to 1 year after radical chemoradiotherapy among nasopharyngeal carcinoma patients.
With the development of radiotherapeutic techniques and equipment as well as advances in treatment modalities, the 5-year overall survival of patients with non-disseminated NPC has exceeded 80%. However, the incidence of hearing toxicity did not decrease significantly compared with the past. The hearing loss remains the second most common toxicity after xerostomia. Audiometry, acoustic impedance testing, eustachian tube pressure measurements, and distortion product otoacoustic emissions will be used to compare hearing before treatment and up to 1 year after radical chemoradiotherapy. The related factors affecting the hearing of NPC patients will also be investigated and explored.
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| Measure | Description | Time Frame |
|---|---|---|
| Hearing level (decibel) | We will use pure tone audiometry to access the hearing level (decibel) before treatment and serially up to 1 year after radical chemoradiotherapy. | up to 16 months |
| The ratio of distortion product otoacoustic emission(DPOAE) failure | We will use distortion product otoacoustic emission(DPOAE) to access the hearing before treatment and serially up to 1 year after radical chemoradiotherapy. | up to 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of Eustachian tube dysfuction(ETD) | We will use eustachian tube pressure measurement to access the eustachian tube function before treatment and serially up to 1 year after radical chemoradiotherapy. | up to 16 months |
| Tympanogram type |
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Inclusion Criteria:
Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
About to undergo radical chemoradiotherapy with intensity-modulated radiotherapy (IMRT).
Eastern Cooperative Oncology Group performance status≤1.
Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin
≥90g/L, and platelet count≥100×10e9/L.
Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST)
≤2.5×upper limit of normal (ULN), and bilirubin≤ 1.5×ULN.
Adequate renal function: creatinine clearance rate≥ 60 ml/min (Cockcroft-Gault formula).
Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
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nasopharyngeal carcinoma patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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We will use acoustic impedance tests to access the tympanogram type before treatment and serially up to 1 year after radical chemoradiotherapy.
| up to 16 months |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |