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

NCT06170021 | Recruiting DMC

• 1 other identifier: 2023-FXY-228
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Radiation-induced Otitis Media

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Effect of the irradiation dose of eustachian tube, tympanum, cochlea, internal auditory tract and vestibule on the occurrence of radiation-induced otitis media

  1 year

• Effect of irradiation dose in the area around of eustachian tube on the severity of ototoxicity after radiotherapy

  1 year

• Effect of irradiation dose of eustachian tube on hearing injury

  1 year

• Effect of different chemoradiotherapy treatment regimens on the occurrence of radiation-induced otitis media

  1 year

• Correlation between radiation-induced otitis media and life quality after radiotherapy

  1 year

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed non-metastatic nasopharyngeal carcinoma patients.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

Related 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.

  PMID: 31178151 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.

  PMID: 2032882 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.

  PMID: 25634060 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.

  PMID: 23835775 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.

  PMID: 26323586 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.

  PMID: 18006095 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: December 18, 2023
• Primary Completion: December 6, 2025
• Study Completion: December 6, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)