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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Incidence of radiation-induced otitis media
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70, regardless of sex.
- •ECOG (Eastern Cooperative Oncology Group) score: 0-
- •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.
排除标准
- •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 >
- •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).
结局指标
主要结局
Incidence of radiation-induced otitis media
时间窗: 1 year
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.
次要结局
- 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 of eustachian tube on hearing injury(1 year)
- Effect of irradiation dose in the area around of eustachian tube on the severity of ototoxicity after radiotherapy(1 year)
- Correlation between radiation-induced otitis media and life quality after radiotherapy(1 year)
- Effect of different chemoradiotherapy treatment regimens on the occurrence of radiation-induced otitis media(1 year)
研究者
Hai-Qiang Mai,MD,PhD
Director of the Department of Nasopharyngeal Carcinoma
Sun Yat-sen University