NCT05757479

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

Efficacy and Safety of Saline Rinses Combined With Steroid-Eluting Stent Implant or Steroid Nasal Spray in Radiation-Related Sinusitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Radiation-Induced Mucositis

Interventions

Type	Name	Description
PROCEDURE	Steroid-eluting stent implantation	The sinus cavity with inflammation receives one bioabsorbable steroid-eluting sinus stent.
DRUG	Steroid nasal spray	1 spray into each nostril once a day.
PROCEDURE	nasal saline rinses	The saltwater runs through nasal passages and drains out of the nostril.

Timeline

• Start date: 2023-02-11
• Primary completion: 2023-12-31
• Completion: 2024-07-01
• First posted: 2023-03-07
• Last updated: 2023-03-07

Locations

1 site across 1 country: China