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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Radiation-Induced Mucositis

Intervention / Treatment
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* Procedure: Steroid-eluting stent implantation
* Drug: Steroid nasal spray
* Procedure: nasal saline rinses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sino-Nasal Outcome Test Scores (SNOT-22) | 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 | 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 | 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) | 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） | 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) | 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 | Rescue medication use of corticosteroids and antibiotics. Specifically, total usage over six month period. | Week 12 and Week 24 | 
| The effective rate | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, Radiation-related sinusitis, Steroid-eluting stent