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This is an observational cohort study to investigate the incidence of radiation-induced otitis media, changes in tubal function and hearing in newly diagnosed nasopharyngeal carcinoma patients without metastasis at multiple time points from baseline to 1 year after radiotherapy.
Patients with newly diagnosed non-metastatic nasopharyngeal carcinoma (AJCC 8th) will be recruited. The incidence of radiation-induced otitis media, eustachian tube function and hearing level in nasopharyngeal carcinoma patients will be prospectively evaluated by magnetic resonance imaging, otoscope, pure tone audiometry, acoustic immittance test and the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) before treatment and serially up to 1 year after radiotherapy. The quality of life of patients will be evaluated before treatment and serially up to 1 year after radiotherapy. The incidence of radiation-induced otitis media, the changes of eustachian tube function and hearing level, together with the influencing factors, in nasopharyngeal carcinoma patients after induction chemotherapy and concurrent chemoradiotherapy will be investigated.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of radiation-induced otitis media | Incidence of radiation-induced otitis media will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by magnetic resonance imaging, otoscope, acoustic immittance test and pure tone audiometry. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the irradiation dose of eustachian tube, tympanum, cochlea, internal auditory tract and vestibule on the occurrence of radiation-induced otitis media | The occurrence of radiation-induced otitis media will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by magnetic resonance imaging, otoscope, acoustic immittance test and pure tone audiometry. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Newly diagnosed non-metastatic nasopharyngeal carcinoma patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiqiang Mai, Dr | Contact | 86-20-8734-3643 | maihq@mail.sysu.edu.cn | |
| Qiuyan Chen, Dr | Contact | 86-20-8734-3380 | chenqy@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31178151 | Background | Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6. | |
| 2032882 | Background | Emami B, Lyman J, Brown A, Coia L, Goitein M, Munzenrider JE, Shank B, Solin LJ, Wesson M. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys. 1991 May 15;21(1):109-22. doi: 10.1016/0360-3016(91)90171-y. |
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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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| Effect of irradiation dose in the area around of eustachian tube on the severity of ototoxicity after radiotherapy | Severity of ototoxictiy will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by magnetic resonance imaging, otoscope, acoustic immittance test, pure tone audiometry and the Eustachian Tube Dysfunction Questionnaire (ETDQ-7). | 1 year |
| Effect of irradiation dose of eustachian tube on hearing injury | The injury of hearing will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by acoustic immittance test and pure tone audiometry. | 1 year |
| Effect of different chemoradiotherapy treatment regimens on the occurrence of radiation-induced otitis media | The occurrence of radiation-induced otitis media will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by magnetic resonance imaging, otoscope, acoustic immittance test and pure tone audiometry. | 1 year |
| Correlation between radiation-induced otitis media and life quality after radiotherapy | The life quality will be assessed prospectively before treatment and serially up to 1 year after radiotherapy. | 1 year |
| 25634060 | Background | Hsin CH, Tseng HC, Lin HP, Chen TH. Post-irradiation otitis media, rhinosinusitis, and their interrelationship in nasopharyngeal carcinoma patients treated by IMRT. Eur Arch Otorhinolaryngol. 2016 Feb;273(2):471-7. doi: 10.1007/s00405-015-3518-8. Epub 2015 Jan 30. |
| 23835775 | Background | Hsin CH, Chen TH, Liang KL, Tseng HC, Liu WS. Postirradiation otitis media with effusion in nasopharyngeal carcinoma patients treated by intensity-modulated radiotherapy. Laryngoscope. 2013 Sep;123(9):2148-53. doi: 10.1002/lary.23215. Epub 2013 Jul 8. |
| 26323586 | Background | Yao JJ, Zhou GQ, Lin L, Zhang WJ, Peng YL, Chen L, Tang LL, Mao YP, Ma J, Sun Y. Dose-volume factors associated with ear disorders following intensity modulated radiotherapy in nasopharyngeal carcinoma. Sci Rep. 2015 Sep 1;5:13525. doi: 10.1038/srep13525. |
| 18006095 | Background | Wang SZ, Wang WF, Zhang HY, Guo M, Hoffman MR, Jiang JJ. Analysis of anatomical factors controlling the morbidity of radiation-induced otitis media with effusion. Radiother Oncol. 2007 Dec;85(3):463-8. doi: 10.1016/j.radonc.2007.10.007. Epub 2007 Nov 19. |
| 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 |