Radiation-Induced MucositisPhase 3NCT05757479
Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis
A Phase 3 study testing Steroid-eluting stent implantation, Steroid nasal spray and nasal saline rinses in people with Radiation-Induced Mucositis, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiation-Induced Mucositis
- What is being tested?
- Steroid-eluting stent implantation, Steroid nasal spray and nasal saline rinses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2023to 1 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- dependence on prolonged corticosteroid therapy for comorbid conditions
- history of allergy to topical steroids
- pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ming-Yuan Chen, MD,PhD, 86-20-8734-2422, chmingy@mail.sysu.edu.cn
About this study
Official title: Efficacy and Safety of Saline Rinses Combined With Steroid-Eluting Stent Implant or Steroid Nasal Spray in Radiation-Related Sinusitis
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.
Read the 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.
- Conditions
- Radiation-Induced Mucositis
- Being tested
- Steroid-eluting stent implantation, Steroid nasal spray, nasal saline rinses
- Keywords
- Nasopharyngeal carcinoma, Radiation-related sinusitis, Steroid-eluting stent
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid-eluting stent implantationProcedure or surgery
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 or surgery
Also called Nasal irrigation
The saltwater runs through nasal passages and drains out of the nostril.
| Study group | Role | What they receive |
|---|---|---|
| Steroid-eluting stent implant | Experimental | Subjects randomized to the experimental group will receive steroid-eluting stent implantation in the affected sinus and saline rinses. Receives: 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. Receives: Drug: Steroid nasal spray; Procedure: nasal saline rinses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline to Week 12
Secondary outcomes (6)
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.
Measured: Change from Baseline to Week 12 and Week 24
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.
Measured: 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）
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.
Measured: Change from Baseline to Week 12 and Week 24
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).
Measured: Change from Baseline to Week 12 and Week 24
Rescue medication
Rescue medication use of corticosteroids and antibiotics. Specifically, total usage over six month period.
Measured: Week 12 and Week 24
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.
Measured: Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start11 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-Induced MucositisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongshan People's Hospital, Guangdong, China, Fifth Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD, PhD, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757479
- Sponsor's protocol ID
- SYSUCC-CMY-2022-sinusitis
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Saline Rinses Combined With Steroid-Eluting Stent Implant or Steroid Nasal Spray in Radiation-Related Sinusitis
- ClinicalTrials.gov ID
- NCT05757479
- Acronym / sponsor ID
- SYSUCC-CMY-2022-sinusitis
- Conditions
- Radiation-Induced Mucositis
- Keywords
- Nasopharyngeal carcinoma, Radiation-related sinusitis, Steroid-eluting stent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Zhongshan People's Hospital, Guangdong, China, Fifth Affiliated Hospital of Guangzhou Medical University
- Study start
- 11 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid-eluting stent implant | Experimental | Procedure: Steroid-eluting stent implantation, Procedure: nasal saline rinsesSubjects randomized to the experimental group will receive steroid-eluting stent implantation in the affected sinus and saline rinses. |
| Nasal steroid spray | Active comparator | Drug: Steroid nasal spray, Procedure: nasal saline rinsesSubjects randomized to the comparator group will receive nasal steroid spray and saline rinses. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steroid-eluting stent implantationThe sinus cavity with inflammation receives one bioabsorbable steroid-eluting sinus stent. | Procedure or surgery | Steroid-eluting stent implant |
| Steroid nasal spray1 spray into each nostril once a day. | Drug | Nasal steroid spray |
| nasal saline rinsesAlso: Nasal irrigationThe saltwater runs through nasal passages and drains out of the nostril. | Procedure or surgery | Nasal steroid spray, Steroid-eluting stent implant |
Primary outcome
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
Time frame: Change from Baseline to Week 12
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 in Lund-Mackay MRI score
Time frame: Change from Baseline to Week 12
Sinus MRI Lund-Mackay (LM) score (0-20). Higher score means more severe disease.
6 secondary outcomes
Lund-Kennedy Scoring for Nasal Endoscopy
Time frame: Change from Baseline to Week 12 and Week 24
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
Time frame: 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）
Time frame: Change from Baseline to Week 12 and Week 24
Change in Quality of life using questionnaires EORTC QLQ-Head&Neck35 (HN35)
Time frame: Change from Baseline to Week 12 and Week 24
Rescue medication
Time frame: Week 12 and Week 24
The effective rate
Time frame: Week 12 and Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Yuan Chen, MD, PhD study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Steroid-eluting stent implantation, Steroid nasal spray and nasal saline rinses in people with Radiation-Induced Mucositis, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yuan Chen, MD, PhD (86-20-8734-3361, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sino-Nasal Outcome Test Scores (SNOT-22) (time frame: Change from Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.