Not Yet RecruitingPhase 3

Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma

168 participantsStarted 2025-10

Plain-language 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 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Otitis Media with Effusion (OME) within 12 months after radiotherapy

Timeframe: From initiation of study intervention (radiotherapy start) until 12 months after completion of radiotherapy.

Trial details

NCT IDNCT07189572

SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

View on ClinicalTrials.gov More Otitis Media trials