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

Radiation-Induced Mucositis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05757479
Study type	Interventional
Source	Sun Yat-sen University
Contact	Ming-Yuan Chen, MD, PhD
Phone	86-20-8734-3361
Email	chmingy@mail.sysu.edu.cn
Status	Recruiting
Phase	Phase 3
Start date	February 11, 2023
Completion date	July 1, 2024

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