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

NCT05757479 | Unknown Phase 3 DMC

• 1 other identifier: SYSUCC-CMY-2022-sinusitis
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-Induced Mucositis

Keywords

Nasopharyngeal carcinoma; Radiation-related sinusitis; Steroid-eluting stent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Lund-Kennedy Scoring for Nasal Endoscopy

  Change from Baseline to Week 12 and Week 24

• Change in Sino-Nasal Outcome Test Scores (SNOT-22)

  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）

  Change from Baseline to Week 12 and Week 24

• Change in Quality of life using questionnaires EORTC QLQ-Head&Neck35 (HN35)

  Change from Baseline to Week 12 and Week 24

• Rescue medication

  Week 12 and Week 24

Study Arms (2)

Steroid-eluting stent implant

EXPERIMENTAL

Subjects randomized to the experimental group will receive steroid-eluting stent implantation in the affected sinus and saline rinses.

Procedure: Steroid-eluting stent implantation; Procedure: nasal saline rinses

Nasal steroid spray

ACTIVE COMPARATOR

Subjects randomized to the comparator group will receive nasal steroid spray and saline rinses.

Drug: Steroid nasal spray; Procedure: nasal saline rinses

Interventions

Steroid-eluting stent implantation PROCEDURE

The sinus cavity with inflammation receives one bioabsorbable steroid-eluting sinus stent.

Steroid-eluting stent implant

Steroid nasal spray DRUG

1 spray into each nostril once a day.

Nasal steroid spray

nasal saline rinses PROCEDURE

The saltwater runs through nasal passages and drains out of the nostril.

Also known as: Nasal irrigation

Nasal steroid spray; Steroid-eluting stent implant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Nasal Lavage

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Ming-Yuan Chen, MD, PhD

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

86-20-8734-3361; chmingy@mail.sysu.edu.cn

Si-Yuan Chen, MD

CONTACT

86-18711150216; chensy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor & chief physician

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 7, 2023
• Study Start: February 11, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

CN (1)