Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170021
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-12-06
Brief Title:
Occurrence of Radiation-induced Otitis Media in Nasopharyngeal Carcinoma Patients After Intensity Modulated Radiotherapy
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 metastasis at multiple time points from baseline to 1 year after radiotherapy
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None