CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 168 target
Drug / intervention
Steroid nasal spray +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05757479
NCT05757479Phase 3Unknown

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

Sun Yat-sen University·interventional·Posted Mar 7, 2023·Updated Mar 7, 2023

In Brief

A Phase 3 clinical trial evaluating Steroid-eluting stent implantation, Steroid nasal spray, and 1 other intervention for Radiation-Induced Mucositis. Targeting 168 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 3UnknownOverdue
202420252026
First PostedMar 7, 2023
Enrollment StartFeb 11, 2023
Primary CompletionDec 31, 2023
Study CompletionJul 1, 2024
TodayJul 1, 2026
Enrollment to primary: 11 monthsPosted 3.3 years ago

Interventions

Steroid-eluting stent implantationprocedure

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

Steroid nasal spraydrug

1 spray into each nostril once a day.

nasal saline rinsesprocedure

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