Clinical trial · Interventional
Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis
Efficacy and Safety of Saline Rinses Combined With Steroid-Eluting Stent Implant or Steroid Nasal Spray in Radiation-Related Sinusitis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation-Induced Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nasal saline rinses | Procedure | — | UNRESOLVED |
| Steroid-eluting stent implantation | Procedure | — | UNRESOLVED |
| Steroid nasal spray | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Steroid-eluting stent implant
- description
- Subjects randomized to the experimental group will receive steroid-eluting stent implantation in the affected sinus and saline rinses.
- interventionNames
- Procedure: Steroid-eluting stent implantation
- Procedure: nasal saline rinses
- type
- ACTIVE_COMPARATOR
- label
- Nasal steroid spray
- description
- Subjects randomized to the comparator group will receive nasal steroid spray and saline rinses.
- interventionNames
- Drug: Steroid nasal spray
- Procedure: nasal saline rinses
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available