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

Sun Yat-sen University

Status: Enrolling

Conditions: Nasopharyngeal Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06170021

2023-FXY-228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).