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.
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).
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.
Parallel
Triamcinolone Acetonide
DrugTriamcinolone acetonide is a medium-potency synthetic corticosteroid. This intervention is administered via a commercially available, metered-dose nasal spray that delivers 55 μg of the active drug per spray. It exerts potent local anti-inflammatory and immunomodulatory effects in the nasal mucosa and Eustachian tube orifice. In this study, it is investigated for the prevention of radiotherapy-induced otitis media with effusion in patients with nasopharyngeal carcinoma.
Placebo
DrugThe placebo nasal spray is specifically formulated to be indistinguishable from the active triamcinolone acetonide nasal spray. It is identical in all physical properties including appearance, scent, taste, packaging, and administration procedure. It contains the same inactive excipients (e.g., preservatives, suspending agents) but does not contain any triamcinolone acetonide or other active pharmaceutical ingredient.
Incidence of Otitis Media with Effusion (OME) within 12 months after radiotherapy
The occurrence of OME is determined by a combination of: 1) Presence of relevant symptoms (e.g., ear fullness, hearing loss); AND 2) Confirmatory physical examination findings on otoscopy (e.g., tympanic membrane retraction, air-fluid levels, bubbles); AND 3) Objective evidence from tympanometry (Type B or Type C curve, indicating middle ear effusion or significant negative pressure). A case of OME is only confirmed if all three criteria are met. The incidence is calculated as the proportion of participants in each group who develop confirmed OME at any point during the 12-month follow-up period after the completion of radiotherapy.
Time to onset of Otitis Media with Effusion (OME)
This measures the time from the start of radiotherapy (baseline) to the first diagnosis of OME. Diagnosis requires the concurrent presence of: 1) relevant symptoms (e.g., ear fullness, hearing loss); 2) confirmatory findings on otoscopy; and 3) a Type B or C tympanogram. The time-to-event data will be analyzed using methods such as Kaplan-Meier curves and Cox proportional hazards models to compare the difference between study arms. Additionally, the proportion of participants with early-onset OME (within 1 month post-radiotherapy) and late-onset OME (after 3 months post-radiotherapy) will be compared between groups using chi-square tests.
Change in pure-tone average hearing threshold
Hearing function is assessed by pure-tone audiometry. The pure-tone average (PTA) will be calculated for low frequencies (500 Hz), medium frequencies (1000, 2000 Hz), and high frequencies (4000 Hz). Change from baseline (pre-radiotherapy) in PTA at each post-treatment timepoint will be calculated and compared between groups. The incidence of clinically significant hearing loss, defined as a threshold shift of ≥15 dB HL at the affected frequencies, will also be compared. The severity of hearing loss will be categorized based on PTA as mild (26-40 dB HL), moderate (41-60 dB HL), or severe (\>60 dB HL).
Tympanometry results
Middle ear function is assessed by tympanometry. Results will be categorized according to standard Jerger classification: Type A (normal), Type B (flat, suggesting effusion), and Type C (negative pressure, suggesting Eustachian tube dysfunction). The distribution of tympanogram types, actual tympanometric peak pressure values (in daPa), and static acoustic compliance values (in mL) will be compared between groups at each timepoint. The primary focus is on the incidence of abnormal tympanograms (Type B or C). Additionally, the conversion rate from an abnormal tympanogram to a normal Type A tympanogram will be analyzed as a measure of recovery.
Change in disease-specific quality of life scores
Description \[\*\] The impact on quality of life is assessed using two validated patient-reported outcome measures: the EORTC QLQ-H\&N35 module (specific to head and neck cancer patients) and the ETDQ-7 questionnaire (specific to Eustachian tube dysfunction). The QLQ-H\&N35 assesses symptoms and social function, while the ETDQ-7 focuses on ear-related symptoms. Change scores from baseline for each questionnaire will be calculated. A decrease in the score represents an improvement in symptoms and quality of life. The mean change in scores at each post-radiotherapy timepoint will be compared between the two study arms.
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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
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