## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** SYSUCC-CMY-2022-sinusitis
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-07

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-03

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-02-11

**Type:** ACTUAL

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2023-03-07
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-13
**Study First Submit QC Date:** 2023-03-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Zhongshan People's Hospital, Guangdong, China

**Class:** OTHER

**Name:** Fifth Affiliated Hospital of Guangzhou Medical University

#### Lead Sponsor

**Class:** OTHER

**Name:** Sun Yat-sen University

#### Responsible Party

**Investigator Affiliation:** Sun Yat-sen University

**Investigator Full Name:** Ming-Yuan Chen

**Investigator Title:** professor & chief physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Radiation-Induced Mucositis

**Keywords:**

- Nasopharyngeal carcinoma

- Radiation-related sinusitis

- Steroid-eluting stent

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 168

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Steroid-eluting stent implantation

- Procedure: nasal saline rinses

**Label:** Steroid-eluting stent implant

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: Steroid nasal spray

- Procedure: nasal saline rinses

**Label:** Nasal steroid spray

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Steroid-eluting stent implant

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

**Name:** Steroid-eluting stent implantation

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Nasal steroid spray

**Description:** 1 spray into each nostril once a day.

**Name:** Steroid nasal spray

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Nasal steroid spray

- Steroid-eluting stent implant

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

**Name:** nasal saline rinses

**Other Names:**

- Nasal irrigation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**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.

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

**Time Frame:** Change from Baseline to Week 12

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

**Measure:** Change in Lund-Mackay MRI score

**Time Frame:** Change from Baseline to Week 12

#### Secondary Outcomes

**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.

**Measure:** Lund-Kennedy Scoring for Nasal Endoscopy

**Time Frame:** Change from Baseline to Week 12 and Week 24

**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.

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

**Time Frame:** Change from Baseline to Week 4 and Week 24

**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.

**Measure:** 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

**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).

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

**Time Frame:** Change from Baseline to Week 12 and Week 24

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

**Measure:** Rescue medication

**Time Frame:** Week 12 and Week 24

**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.

**Measure:** The effective rate

**Time Frame:** Week 12 and Week 24

### Eligibility Module

**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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chmingy@mail.sysu.edu.cn

**Name:** Ming-Yuan Chen, MD, PhD

**Phone:** 86-20-8734-3361

**Role:** CONTACT

**Contact 2:**

**Email:** chensy@sysucc.org.cn

**Name:** Si-Yuan Chen, MD

**Phone:** 86-18711150216

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** chmingy@mail.sysu.edu.cn

- **Name:** Ming-Yuan Chen, MD,PhD

- **Phone:** 86-20-8734-2422

- **Role:** CONTACT

**Country:** China

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

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510060

#### Overall Officials

**Official 1:**

**Affiliation:** Sun Yat-sen University

**Name:** Ming-Yuan Chen, MD, PhD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000010254

- Term: Paranasal Sinus Diseases

- ID: D000009668

- Term: Nose Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M1730

- Name: Nasopharyngeal Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M26955

- Name: Mucositis

- Relevance: HIGH

- As Found: Mucositis

- ID: M15657

- Name: Sinusitis

- Relevance: HIGH

- As Found: Sinusitis

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13167

- Name: Paranasal Sinus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12604

- Name: Nose Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4047

- Name: Nasopharyngeal Carcinoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012852

- Term: Sinusitis

- ID: D000052016

- Term: Mucositis

### Misc Info Module

- Version Holder: 2024-05-24
