Clinical trial NCT06170021: Occurrence of Radiation-induced Otitis Media in Nasopharyngeal Carcinoma Patients After Intensity Modulated Radiotherapy
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Radiation-induced Otitis Media
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed non-metastatic nasopharyngeal carcinoma patients.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of radiation-induced otitis media
timeFrame: 1 year
Secondary outcomes:
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
measure: Effect of irradiation dose in the area around of eustachian tube on the severity of ototoxicity after radiotherapy
timeFrame: 1 year
measure: Effect of irradiation dose of eustachian tube on hearing injury
timeFrame: 1 year
measure: Effect of different chemoradiotherapy treatment regimens on the occurrence of radiation-induced otitis media
timeFrame: 1 year
measure: Correlation between radiation-induced otitis media and life quality after radiotherapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.