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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170021
• Other study ID #: 2023-FXY-228
• Status: Recruiting
• Start date: December 6, 2023
• Est. completion date: December 6, 2025

Study information

• Verified date: December 2023
• Source: Sun Yat-sen University
• Contact: Haiqiang Mai, Dr
• Phone: 86-20-8734-3643
• Email: maihq[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: December 6, 2025
• Est. primary completion date: December 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Otitis
• Otitis Media

Locations

Country	Name	City	State
China	Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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