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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757479
• Other study ID #: SYSUCC-CMY-2022-sinusitis
• Status: Recruiting
• Phase: Phase 3
• Start date: February 11, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2023
• Source: Sun Yat-sen University
• Contact: Ming-Yuan Chen, MD, PhD
• Phone: 86-20-8734-3361
• Email: chmingy[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: July 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Radiation-Induced Mucositis
• Sinusitis

Intervention

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.

Locations

Country	Name	City	State
China	Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Fifth Affiliated Hospital of Guangzhou Medical University, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rescue medication	Rescue medication use of corticosteroids and antibiotics. Specifically, total usage over six month period.	Week 12 and Week 24
Secondary	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