Occurrence of Radiation-induced Otitis Media in Nasopharyngeal Carcinoma Patients After Intensity Modulated Radiotherapy

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Incidence of radiation-induced otitis media [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Effect of the irradiation dose of eustachian tube, tympanum, cochlea, internal auditory tract and vestibule on the occurrence of radiation-induced otitis media [Срок оценки: 1 year]
• Effect of irradiation dose in the area around of eustachian tube on the severity of ototoxicity after radiotherapy [Срок оценки: 1 year]
• Effect of irradiation dose of eustachian tube on hearing injury [Срок оценки: 1 year]
• Effect of different chemoradiotherapy treatment regimens on the occurrence of radiation-induced otitis media [Срок оценки: 1 year]
• Correlation between radiation-induced otitis media and life quality after radiotherapy [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center — Гуанчжоу

Публикации

• 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. PMID 31178151
• 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. PMID 2032882
• 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. PMID 25634060
• 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. PMID 23835775
• 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. PMID 26323586
• 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. PMID 18006095

Идентификаторы

NCT: NCT06170021 · 2023-FXY-228

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗