Status:
NOT_YET_RECRUITING
Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Sun Yat-sen University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Otitis Media
Otitis Media With Effusion After Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study focuses on a common side effect experienced by many patients after radiation therapy for nasopharyngeal cancer, which is a type of head and neck cancer. This side effect is called secretory...
Detailed Description
Background and Rationale: Nasopharyngeal carcinoma (NPC) is endemic in Southern China. While radiotherapy has significantly improved survival rates, radiation-induced complications severely impact qu...
Eligibility Criteria
Inclusion
- Pathologically confirmed nasopharyngeal carcinoma scheduled for curative intensity-modulated radiation therapy (IMRT), with or without concurrent chemotherapy.
- Age between 18 and 75 years.
- No previous history of head and neck radiotherapy.
- Intact tympanic membranes bilaterally at baseline, with no history of middle ear surgery (including tympanostomy tube placement).
- Willing to comply with all study procedures, including nasal spray use, audiological examinations, and follow-up visits.
- No use of systemic or topical corticosteroids, antihistamines, or decongestants within 14 days prior to randomization.
- All inclusion criteria must be met for participation
Exclusion
- Diagnosed with complete conductive hearing loss or ossicular chain fixation.
- Scheduled to undergo tympanostomy tube placement, tympanotomy, or other middle ear surgery prior to randomization.
- Unlikely to complete the 12-month follow-up (e.g., planned relocation, poor compliance).
- Presence of respiratory conditions requiring treatment with nasal corticosteroids.
- Known allergy or hypersensitivity to nasal corticosteroids (especially triamcinolone acetonide or its excipients).
- History of severe mental illness, cognitive impairment, or substance abuse that may affect compliance.
- Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
- Participation in other investigational drug clinical trials within the past 3 months.
- Deemed unsuitable for the trial by the investigator (e.g., severe septal deviation, chronic rhinosinusitis requiring systemic treatment, or poorly controlled diabetes).
- Any subject who meets any of the above exclusion criteria at baseline will be excluded from the study.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT07189572
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 29 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.