Status:
RECRUITING
Occurrence of Radiation-induced Otitis Media in Nasopharyngeal Carcinoma Patients After Intensity Modulated Radiotherapy
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
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...
Detailed 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 nasop...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 6 2025
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT06170021
Start Date
December 18 2023
End Date
December 6 2025
Last Update
August 6 2024
Active Locations (1)
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1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060