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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

October 31, 2027

Conditions
Otitis MediaOtitis Media With Effusion After Nasopharyngeal CarcinomaRadiotherapy Side EffectsRadiotherapy Side EffectOtitis Media With Effusion (OME)
Interventions
DRUG

Triamcinolone Acetonide

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.

DRUG

Placebo

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.

All Listed Sponsors
collaborator

Sun Yat-sen University

OTHER

collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

lead

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

OTHER