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

NCT07189572 | Not Yet Recruiting Phase 3

• 1 other identifier: UHCT250873
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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 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

Otitis Media; Otitis Media With Effusion After Nasopharyngeal Carcinoma; Radiotherapy Side Effects; Radiotherapy Side Effect; Otitis Media With Effusion (OME)

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (4)

• Time to onset of Otitis Media with Effusion (OME)

  From the start of radiotherapy until the first occurrence of OME, assessed up to 12 months after radiotherapy completion.

• Change in pure-tone average hearing threshold

  Baseline (pre-radiotherapy), and at 3 month, 6 months, and 12 months after completion of radiotherapy.

• Tympanometry results

  Baseline (pre-radiotherapy), and at 3 month, 6 months, and 12 months after completion of radiotherapy.

• Change in disease-specific quality of life scores

  Baseline (pre-radiotherapy), and at 3 months, 6 months, and 12 months after completion of radiotherapy.

Study Arms (2)

Triamcinolone Acetonide Nasal Spray

EXPERIMENTAL

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.

Drug: Triamcinolone Acetonide

Placebo Nasal Spray

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Triamcinolone Acetonide DRUG

Triamcinolone 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.

Triamcinolone Acetonide Nasal Spray

Placebo DRUG

The 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.

Placebo Nasal Spray

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Sun Yat-sen University: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

MeSH Terms

Conditions

Otitis Media; Radiation Injuries; Otitis Media with Effusion

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09