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

RECRUITINGSponsored by Sun Yat-sen University
Actively Recruiting
SponsorSun Yat-sen University
Started2023-12-18
Est. completion2025-12-06
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
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).

Conditions2

CancerNasopharyngeal Carcinoma

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