Comparing new and traditional classifications of radiation oropharyngeal mucositis
Official title: A Comparative Study on the Evaluation Consistency Between the New Type and the Traditional Grade of Radioactive Oropharyngeal Mucositis and the Exploration of Blood Markers
Run by Nanfang Hospital, Southern Medical University · NCT06307327 · Data updated 2026-11-12
This study is testing a new way to classify the painful mouth sores caused by radiation in head and neck cancer patients to see if it helps doctors agree more on how severe they are.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 264 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 4 sites (Guangzhou, Guangdong and 3 other locations) |
| Status | Recruiting |
| Started | September 2025 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | July 16, 2025 |
| Trial ID | NCT06307327 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with histologically confirmed head and neck tumors undergoing radiotherapy or chemoradiotherapy.
✕Probably not a fit
Patients with uncontrolled serious medical conditions or severe allergies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to address the inconsistencies in the traditional grading system for radiation oropharyngeal mucositis, a painful side effect of radiotherapy in head and neck cancer patients. Researchers will classify mucositis into four types based on histopathological changes and compare the assessment consistency among different physicians using both new and traditional classifications. Additionally, the study will explore changes in blood markers associated with the different types of mucositis using clinical residual blood samples. The multicenter approach involves several hospitals in Guangdong, China.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment and treatment of radiation oropharyngeal mucositis, enhancing patient quality of life.
How similar studies have gone: While there may be existing studies on mucositis, this innovative classification approach is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntarily sign informed consent; * Age 18 or older on the date of signing the informed consent; * Histologically confirmed head and neck tumor, radiotherapy or chemoradiotherapy. Exclusion Criteria: * They also have other uncontrolled serious medical conditions, such as unstable heart disease requiring treatment, poorly controlled diabetes (fasting blood glucose \> 1.5× the upper limit of normal), mental illness, and a history of severe allergies
Where it's running
-
Southern medical university
Guangzhou, Guangdong, China Recruiting -
Huizhou Central People's Hospital
Huizhou, Guangdong, China Not yet recruiting -
Jieyang people's hospital
Jieyang, Guangdong, China Not yet recruiting -
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Meizhou, Guangdong, China Not yet recruiting
Study contacts
- Principal investigator: Jian Guan, M.D — Nanfang Hospital, Southern Medical University
- Study coordinator: Jian Guan, M.D
- Email: guanjian5461@163.com
- Phone: +86-13632102247
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.