Clinical trial · Observational
Occurrence of Radiation-induced Otitis Media in Nasopharyngeal Carcinoma Patients After Intensity Modulated Radiotherapy
Effect of Irradiation Dose to Eustachian Tube and Surrounding Auditory Organs on the Occurrence of Radiation-induced Otitis Media in Nasopharyngeal Carcinoma Patients During Intensity Modulated Radiotherapy Era: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of radiation-induced otitis media
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (5)
- measure
- Effect of the irradiation dose of eustachian tube, tympanum, cochlea, internal auditory tract and vestibule on the occurrence of radiation-induced otitis media
- timeFrame
- 1 year
- description
- 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.
- measure
- Effect of irradiation dose in the area around of eustachian tube on the severity of ototoxicity after radiotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70, regardless of sex. * ECOG (Eastern Cooperative Oncology Group) score: 0-1. * Patients must sign informed consent and be willing, and well understood the objective and procedure of this study. * Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I-IVa (according to the 8th American Joint Committee on Cancer \[AJCC\] edition. * No radiotherapy or chemotherapy was administered before enrollment. * Expected survival time ≥ 6 months. Exclusion Criteria: * Women in pregnancy or lactation. * Patients with significantly lower heart, liver, lung, kidney, bone marrow function and other severe medical condition. * Prior to radiotherapy, there is a clear underlying disease of the eustachian tube or other ear diseases. * Patients with otitis media before radiotherapy and have no improvement at the end of radiotherapy. * Patients with history of middle ear, nasal or nasopharyngeal surgery on the affected side. * Patients combined with congenital cleft palate and other craniofacial abnormalities. * Patients with histologically confirmed keratinizing nasopharyngeal carcinoma, type of WHO I. * Patients with recurrence and distant metastasis. * Patients with radiotherapy or chemotherapy before. * Age \< 18 or age \> 70. * Patients who changed their initial treatment regimen during the observation period due to disease progression (including tumor residual after radiotherapy, tumor recurrence, and new distant metastases).
References
Publications (6)
- BACKGROUNDChen 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. PMID 31178151
- BACKGROUNDEmami 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. PMID 2032882
- BACKGROUNDHsin 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. PMID 25634060
- BACKGROUNDHsin 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. PMID 23835775
- BACKGROUNDYao 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. PMID 26323586
- BACKGROUNDWang 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. PMID 18006095