Comparing new and traditional classifications of radiation oropharyngeal mucositis
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
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 |
|---|---|
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 4 sites (Guangzhou, Guangdong and 3 other locations) |
| Trial ID | NCT06307327 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed head and neck tumors undergoing radiotherapy or chemoradiotherapy.
Not a fit: Patients with uncontrolled serious medical conditions or severe allergies may not benefit from this study.
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 performed: While there may be existing studies on mucositis, this innovative classification approach is relatively novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.