Actively Recruiting
Comparative Study of New and Traditional Classifications of Radioactive Oropharyngeal Mucositis and Exploration of Blood Markers
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-07-16
264
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve the evaluation of radiation oropharyngeal mucositis, a painful side effect experienced by patients undergoing radiotherapy for head and neck tumors. The study compares a new four-type classification system based on histopathological changes with traditional grading methods. It also explores changes in blood markers related to different types of mucositis by using residual blood samples from patients. The study is observational and does not require any extra visits or tests beyond routine clinical care. It is divided into three parts: first, comparing the consistency of different mucositis assessment methods among doctors; second, evaluating the stability of these assessments across multiple doctors; and third, comparing doctor assessments using the new classification with patients' self-assessments. Patients are assessed every 1 to 2 weeks during radiotherapy. Participants will provide consent for data collection, including routine diagnosis and treatment information. Researchers will measure the consistency between doctors' evaluations and between doctors and patients over up to three years. Patient and doctor satisfaction with the assessment methods will also be recorded. The main outcome is inter-rater consistency among doctors, with monitoring continuing throughout the study period.
CONDITIONS
Brief Title
Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent
- Age 18 years or older at consent
- Histologically confirmed head and neck tumor
- Currently receiving radiotherapy or chemoradiotherapy
You will not qualify if you...
- Uncontrolled serious medical conditions such as unstable heart disease requiring treatment
- Poorly controlled diabetes with fasting blood glucose over 1.5 times the upper limit of normal
- Mental illness
- History of severe allergies
- Other uncontrolled serious medical conditions that may affect participation or safety during the study period
- Unwillingness or inability to provide informed consent or comply with study procedures
- Any condition that, in the opinion of the investigator, may interfere with study participation or data integrity
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 clinical care for head and neck tumors receiving radiotherapy or chemoradiotherapy are observed. Different doctors assess mucositis severity and participants provide self-assessments approximately every 1 to 2 weeks during their radiotherapy treatment.
Assessments every 1 to 2 weeks during radiotherapy
Trial Site Locations
Total: 4 locations
1
Southern medical university
Guangzhou, Guangdong, China, 510515
Actively Recruiting
2
Huizhou Central People's Hospital
Huizhou, Guangdong, China, 516000
Not Yet Recruiting
3
Jieyang people's hospital
Jieyang, Guangdong, China, 522000
Not Yet Recruiting
4
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Meizhou, Guangdong, China, 514000
Not Yet Recruiting
Research Team
J
Jian Guan, M.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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