Clinical trial NCT05757479: Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis
Official title: Efficacy and Safety of Saline Rinses Combined With Steroid-Eluting Stent Implant or Steroid Nasal Spray in Radiation-Related Sinusitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Radiation-Induced Mucositis
Keywords: Nasopharyngeal carcinoma
Radiation-related sinusitis
Steroid-eluting stent
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Zhongshan People's Hospital, Guangdong, China
name: Fifth Affiliated Hospital of Guangzhou Medical University
First posted: 2023-03-07
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sino-Nasal Outcome Test Scores (SNOT-22)
timeFrame: Change from Baseline to Week 12
measure: Change in Lund-Mackay MRI score
timeFrame: Change from Baseline to Week 12
Secondary outcomes:
measure: Lund-Kennedy Scoring for Nasal Endoscopy
timeFrame: Change from Baseline to Week 12 and Week 24
measure: Change in Sino-Nasal Outcome Test Scores (SNOT-22)
timeFrame: Change from Baseline to Week 4 and Week 24
measure: Change in Quality of life using The European Organization for Research and Treatment of Cancer core quality of life questionnaire（EORTC QLQ-30）
timeFrame: Change from Baseline to Week 12 and Week 24
measure: Change in Quality of life using questionnaires EORTC QLQ-Head&Neck35 (HN35)
timeFrame: Change from Baseline to Week 12 and Week 24
measure: Rescue medication
timeFrame: Week 12 and Week 24
measure: The effective rate
timeFrame: Week 12 and Week 24
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming-Yuan Chen, MD, PhD
role: STUDY_CHAIR
References: