About this trial
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 otitis media (fluid buildup in the middle ear). It can cause a feeling of fullness in the ear and hearing loss. While procedures like ear tube placement can help, they can also lead to other problems like ear infections and drainage.
Radiation treatment is thought to cause inflammation that disrupts the normal function of the tube connecting the ear to the throat (Eustachian tube), leading to this fluid buildup. A nasal spray containing a steroid medicine (triamcinolone acetonide) is already known to be safe and effective at reducing inflammation in the ear fluid of both children and adults. We believe that using this spray may also help prevent and improve this condition in nasopharyngeal cancer patients after radiation therapy.
The main goal of this study is to explore whether this nasal spray can effectively prevent or reduce fluid buildup in the ear following radiation therapy. We hope this non-invasive treatment will provide a new option to improve the quality of life for these patients.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Triamcinolone Acetonide
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator