Clinical trial · Interventional
Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma
Efficacy of Intranasal Corticosteroid Spray in Preventing Otitis Media With Effusion After Radiotherapy for Nasopharyngeal Carcinoma: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Otitis Media | — | UNRESOLVED | — |
| Otitis Media With Effusion After Nasopharyngeal Carcinoma | — | UNRESOLVED | — |
| Otitis Media With Effusion (OME) | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
| Radiotherapy Side Effects | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Triamcinolone Acetonide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Triamcinolone Acetonide Nasal Spray
- description
- Participants will receive triamcinolone acetonide nasal spray (55 μg/spray) in addition to concurrent cisplatin-based chemoradiation. The intervention is initiated on day 1 of radiotherapy. The dosing regimen is 2 sprays per nostril (total daily dose of 220 μg) administered each morning for 12 weeks, covering the entire radiotherapy course and the acute inflammatory phase. All patients will also perform daily nasal irrigation with normal saline, timed at least 30 minutes apart from the drug administration.
- interventionNames
- Drug: Triamcinolone Acetonide
- type
- PLACEBO_COMPARATOR
- label
- Placebo Nasal Spray
- description
- Participants will receive a matching placebo nasal spray, which is identical in appearance and usage to the active drug, in addition to concurrent cisplatin-based chemoradiation. The intervention is initiated on day 1 of radiotherapy. The dosing regimen is 2 sprays per nostril administered each morning for 12 weeks. All patients will also perform daily nasal irrigation with normal saline, timed at least 30 minutes apart from the placebo administration.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 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.
References
Publications (0)
Data not yet available