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

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Primary Purpose

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Steroid-eluting stent implantation

Steroid nasal spray

nasal saline rinses

About this trial

This is an interventional treatment trial for Radiation-Induced Mucositis focused on measuring Nasopharyngeal carcinoma, Radiation-related sinusitis, Steroid-eluting stent

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Steroid-eluting stent implant

Nasal steroid spray

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 in Lund-Mackay MRI score

Sinus MRI Lund-Mackay (LM) score (0-20). Higher score means more severe disease.

Secondary Outcome Measures

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.

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 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.

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).

Rescue medication

Rescue medication use of corticosteroids and antibiotics. Specifically, total usage over six month period.

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.

Full Information

NCT ID

NCT05757479

First Posted

February 13, 2023

Last Updated

March 3, 2023

Sponsor

Sun Yat-sen University

Collaborators

Zhongshan People's Hospital, Guangdong, China, Fifth Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05757479

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Zhongshan People's Hospital, Guangdong, China, Fifth Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiation-Induced Mucositis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Steroid-eluting stent implant

Arm Type

Experimental

Arm Description

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

Arm Title

Nasal steroid spray

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Steroid-eluting stent implantation

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Steroid nasal spray

Intervention Description

1 spray into each nostril once a day.

Intervention Type

Procedure

Intervention Name(s)

nasal saline rinses

Other Intervention Name(s)

Nasal irrigation

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Change from Baseline to Week 12

Title

Change in Lund-Mackay MRI score

Description

Sinus MRI Lund-Mackay (LM) score (0-20). Higher score means more severe disease.

Time Frame

Change from Baseline to Week 12

Secondary Outcome Measure Information:

Title

Lund-Kennedy Scoring for Nasal Endoscopy

Description

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.

Time Frame

Change from Baseline to Week 12 and Week 24

Title

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

Description

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.

Time Frame

Change from Baseline to Week 4 and Week 24

Title

Change in Quality of life using The European Organization for Research and Treatment of Cancer core quality of life questionnaire（EORTC QLQ-30）

Description

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.

Time Frame

Change from Baseline to Week 12 and Week 24

Title

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

Description

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).

Time Frame

Change from Baseline to Week 12 and Week 24

Title

Rescue medication

Description

Rescue medication use of corticosteroids and antibiotics. Specifically, total usage over six month period.

Time Frame

Week 12 and Week 24

Title

The effective rate

Description

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.

Time Frame

Week 12 and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming-Yuan Chen, MD, PhD

Phone

86-20-8734-3361

Email

chmingy@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Si-Yuan Chen, MD

Phone

86-18711150216

Email

chensy@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming-Yuan Chen, MD, PhD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming-Yuan Chen, MD,PhD

Phone

86-20-8734-2422

Email

chmingy@mail.sysu.edu.cn

Radiation-Induced Mucositis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial