Actively Recruiting

Age: 18Years +
All Genders
ID06287788

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Loading map...

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

Similar Trials

A Real-world Observational Study of a Mucosal Contouring Met...

Radiation-induced Oropharyngeal Mucositis

Actively Recruiting

10 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here