Investigating ear complications in nasopharyngeal cancer patients after radiation therapy
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
This study is testing how radiation therapy for nasopharyngeal cancer affects ear problems, hearing, and quality of life in newly diagnosed patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 215 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06170021 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the incidence of radiation-induced otitis media and assess changes in eustachian tube function and hearing in patients newly diagnosed with non-metastatic nasopharyngeal carcinoma. Participants will undergo a series of assessments, including magnetic resonance imaging and audiometric tests, before treatment and at multiple time points up to one year post-radiotherapy. The study will also explore the quality of life of these patients throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed, non-metastatic nasopharyngeal carcinoma.
Not a fit: Patients with pre-existing ear conditions or those who have undergone prior treatments for nasopharyngeal carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for ear complications in nasopharyngeal carcinoma patients undergoing radiotherapy.
How similar studies have performed: While similar studies have explored radiation effects on ear health, this specific investigation into nasopharyngeal carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Guangzhou, Guangdong
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Haiqiang Mai, Dr
- Email: maihq@mail.sysu.edu.cn
- Phone: 86-20-8734-3643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.