Actively Recruiting
Prediction of Radiation-Induced Oropharyngeal Mucositis Using a Swallowing-Induced Breakthrough Pain Mucosal Contouring Method in Nasopharyngeal Carcinoma Patients: An Observational Study
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-03-01
240
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new way to predict severe oropharyngeal mucositis caused by radiation therapy in patients with nasopharyngeal carcinoma (NPC), a cancer common in southern China. The study focuses on a mucosal contouring method based on swallowing-induced breakthrough pain, which showed better prediction results than previous methods. This prospective, multicenter, observational study aims to further evaluate the effectiveness of this new predictive approach. The study observes patients with NPC who are undergoing radical radiotherapy or chemoradiotherapy. Researchers will use the new mucosal delineation method to assess radiation-induced oropharyngeal mucositis by monitoring swallowing-induced breakthrough pain. This method aims to identify patients at high risk for severe mucositis to help guide timely interventions, although no specific treatments are provided within the study. Participants will be monitored throughout the study period, which can last up to three years. Researchers will collect continuous records of mucositis severity and self-reported pain during swallowing. The study measures the accuracy of the predictive model using various statistical tools like AUC, sensitivity, and specificity. Safety and other important predictors of mucositis will also be evaluated, with no additional treatments or interventions required for participants.
CONDITIONS
Brief Title
A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed written consent.
- Age 18 years or older.
- Histologically confirmed nasopharyngeal carcinoma.
- Currently undergoing radical radiotherapy or chemoradiotherapy.
- Have complete and continuous records of oral/oropharyngeal mucositis grading and self-reported swallowing-induced breakthrough pain.
You will not qualify if you...
- Poor oral hygiene, untreated dental or periodontal diseases, or metal dental restorations.
- Untreated or unresolved unstable heart diseases requiring treatment.
- Poorly controlled diabetes mellitus.
- Body mass index (BMI) less than 18.5.
- Deemed unsuitable to participate by researchers.
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 who undergo routine radiotherapy or chemoradiotherapy are observed for the occurrence and severity of oropharyngeal mucositis and swallowing-induced breakthrough pain.
Regular assessments during treatment and follow-up
Trial Site Locations
Total: 1 location
1
Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively 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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