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

Last updated: March 3, 2023
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Sinusitis

Mucositis

Treatment

N/A

Clinical Study ID

NCT05757479
SYSUCC-CMY-2022-sinusitis
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 NasalPolyps 2020
  • SNOT-22 ≥ 20 and MRI Lund-Mackay score > 8
  • 18-70 years old

Exclusion

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

Study Design

Total Participants: 168
Study Start date:
February 11, 2023
Estimated Completion Date:
July 01, 2024

Study 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.

Connect with a study center

  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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