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

March 3, 2023 updated by: Ming-Yuan Chen, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Steroid-eluting stent implant
Subjects randomized to the experimental group will receive steroid-eluting stent implantation in the affected sinus and saline rinses.
Procedure: Steroid-eluting stent implantation
The sinus cavity with inflammation receives one bioabsorbable steroid-eluting sinus stent.
Procedure: nasal saline rinses
The saltwater runs through nasal passages and drains out of the nostril.
Other Names:
  • Nasal irrigation
Active Comparator: Nasal steroid spray
Subjects randomized to the comparator group will receive nasal steroid spray and saline rinses.
Procedure: nasal saline rinses
The saltwater runs through nasal passages and drains out of the nostril.
Other Names:
  • Nasal irrigation
Drug: Steroid nasal spray
1 spray into each nostril once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
Time Frame: Change from Baseline to Week 12
The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome.
Change from Baseline to Week 12
Change in Lund-Mackay MRI score
Time Frame: Change from Baseline to Week 12
Sinus MRI Lund-Mackay (LM) score (0-20). Higher score means more severe disease.
Change from Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lund-Kennedy Scoring for Nasal Endoscopy
Time Frame: Change from Baseline to Week 12 and Week 24
The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.
Change from Baseline to Week 12 and Week 24
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
Time Frame: Change from Baseline to Week 4 and Week 24
The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome.
Change from Baseline to Week 4 and Week 24
Change in Quality of life using The European Organization for Research and Treatment of Cancer core quality of life questionnaire（EORTC QLQ-30）
Time Frame: Change from Baseline to Week 12 and Week 24
Comparison of quality of life using questionnaires EORTC QLQ-30. All EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom-atology.
Change from Baseline to Week 12 and Week 24
Change in Quality of life using questionnaires EORTC QLQ-Head&Neck35 (HN35)
Time Frame: Change from Baseline to Week 12 and Week 24
Comparison of quality of life using questionnaires HN35. HN35 score ranges from zero to 100. A high score for a functional or global scale represents a relatively high/healthy level of functioning or global quality of life, whereas a high score for a symptom scale represents the presence of a symptom or problem(s).
Change from Baseline to Week 12 and Week 24
Rescue medication
Time Frame: Week 12 and Week 24
Rescue medication use of corticosteroids and antibiotics. Specifically, total usage over six month period.
Week 12 and Week 24
The effective rate
Time Frame: Week 12 and Week 24

Cure: the symptoms disappeared, sinus ostium open, and the sinus mucosa was epithelialized without purulent secretions.

Improved: the symptoms were significantly improved. Endoscopic examination showed edema, hypertrophy or granulation tissue formation in some areas of sinus mucosa, and a small amount of purulent secretions.

Ineffective: the symptoms were not improved. Endoscopic examination showed stenosis or atresia of the sinus ostium, formation of polyps or purulent secretions.
Week 12 and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Zhongshan People's Hospital, Guangdong, China
Fifth Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Estimate)

March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-CMY-2022-sinusitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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