Actively Recruiting
A Real-world Observational Study of a Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Predicting Radiation-induced Oropharyngeal Mucositis in Nasopharyngeal Carcinoma
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-03-13
718
Participants Needed
10
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new mucosal contouring method to predict radiation-induced oropharyngeal mucositis in patients with nasopharyngeal carcinoma (NPC). This condition, which causes swallowing-induced breakthrough pain, greatly affects patients' quality of life during radiotherapy. Previous prediction models using oral cavity or mucosa surface contouring were not satisfactory, so this study aims to further evaluate a method based on mucosal areas linked to breakthrough pain in a real-world, multicenter observational setting. This observational study will follow patients with locally advanced NPC undergoing radical radiotherapy or chemoradiotherapy. The study focuses on assessing how well the mucosal delineation method predicts the occurrence and severity of oropharyngeal mucositis by tracking swallowing-induced breakthrough pain. There are no investigational treatments involved; instead, patients are observed and data is collected during their standard care. Participants will have their oral or oropharyngeal mucositis severity and swallowing pain recorded continuously throughout their treatment. Researchers will analyze the predictive model's performance by measuring accuracy, sensitivity, specificity, and other statistical values over up to three years. The study will help improve risk assessment and early intervention for mucositis in NPC patients, with all data collected during their regular clinical visits.
CONDITIONS
Brief Title
A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed written consent.
- Be 18 years of age or older.
- Have a confirmed diagnosis of nasopharyngeal carcinoma.
- Currently undergoing radical radiotherapy or chemoradiotherapy.
- Have complete and continuous records of oral or oropharyngeal mucositis grading and self-reported swallowing-induced breakthrough pain.
You will not qualify if you...
- Have poor oral hygiene, untreated dental or periodontal diseases, or metal dental restorations.
- Have untreated or unresolved unstable heart diseases requiring treatment.
- Have poorly controlled diabetes mellitus.
- Have a body mass index (BMI) less than 18.5.
- Be assessed by researchers as unsuitable to participate in the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo evaluation involving mucosal contouring based on swallowing-induced breakthrough pain to predict radiation-induced oropharyngeal mucositis.
Regular assessments during radiotherapy and follow-up
Duration - Up to 3 years
Participants are observed over time to monitor the occurrence and severity of radiation-induced oropharyngeal mucositis and validate predictive models.
Ongoing periodic visits as part of routine care
Trial Site Locations
Total: 10 locations
1
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
2
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, China
Actively Recruiting
3
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
4
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Not Yet Recruiting
5
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
6
Yuebei People's Hospital
Shaoguan, Guangdong, China
Not Yet Recruiting
7
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
8
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, China
Not Yet Recruiting
9
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
10
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
Research Team
J
Jian Guan, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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