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Simple nasal spray may prevent hearing loss in cancer survivors

NCT ID NCT07189572

Prevention Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a steroid nasal spray can prevent fluid buildup in the middle ear, a common side effect of radiation therapy for nasopharyngeal cancer. About 168 adults who are about to start radiation will use either the spray or a placebo for 12 months. The goal is to see if this simple, non-invasive treatment can reduce ear fullness and hearing loss, improving quality of life without the need for ear tubes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 168 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

nasopharyngeal carcinoma otitis media radiation injury otitis media with effusion prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Otitis media Otitis media with effusion (OME) Otitis media with effusion after nasopharyngeal carcinoma Radiotherapy side effect Radiotherapy side effects

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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More trials for these conditions

Other studies related to the condition(s) this trial covers.