Actively Recruiting
Observational Study on Predicting Radiation-Induced Oropharyngeal Mucositis Using a New Mucosal Contouring Method in Nasopharyngeal Carcinoma Patients
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 models 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.
Research Team
J
Jian Guan, Ph.D.
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