Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Radiation-Induced Mucositis

Treatments: Drug: Steroid nasal spray; Procedure: Steroid-eluting stent implantation; Procedure: nasal saline rinses

Study type: Interventional

Funder types: Other

Identifiers

NCT05757479

SYSUCC-CMY-2022-sinusitis

Details and patient eligibility

About

Sinusitis is one of the most common sequelae after radiotherapy among nasopharyngeal carcinoma patients. While local steroids have been shown to be effective in the management of patients with chronic rhinosinusitis, their role in treating radiation-related sinusitis is ambiguous. Poor adherence to nasal steroid spray often contributes to the failure of symptom relief. The aim of this study is to determine if steroids stents implantation into the sinuses could improve patient outcomes in radiation-related sinusitis.

Full description

Investigators aim to assess the efficacy and safety of Steroid-eluting stents when implanted in sinus in patients with radiation-related sinusitis. This phase III randomized controlled study enrolled nasopharyngeal carcinoma patients who received radiotherapy and developed severe radiation-related sinusitis. Subjects were randomly assigned to receive steroid-eluting stents implantation or nasal steroid spray. All study patients also received saline rinses.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pathologically confirmed nasopharyngeal carcinoma patients
• finished radical radiotherapy (≥66Gy) for at least 3 months
• tumor complete response
• received appropriate medical treatment for sinusitis during or after radiotherapy
• confirmed sinusitis according to European Position Paper on Rhinosinusitis and Nasal Polyps 2020
• SNOT-22 ≥ 20 and MRI Lund-Mackay score > 8
• 18-70 years old

Exclusion criteria

• anatomic variation resulted in occluded ostiomeatal complex
• Karnofsky score ≤ 70
• life-threatening medical conditions
• tumour residue or recurrence
• acute bacterial sinusitis or acute fungal sinusitis
• cystic fibrosis or primary ciliary dyskinesia
• dependence on prolonged corticosteroid therapy for comorbid conditions
• history of allergy to topical steroids
• pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

Steroid-eluting stent implant

Experimental group

Description:

Subjects randomized to the experimental group will receive steroid-eluting stent implantation in the affected sinus and saline rinses.

Treatment:

Procedure: Steroid-eluting stent implantation

Procedure: nasal saline rinses

Nasal steroid spray

Active Comparator group

Description:

Subjects randomized to the comparator group will receive nasal steroid spray and saline rinses.

Treatment:

Procedure: nasal saline rinses

Drug: Steroid nasal spray