Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Radiation-Induced Mucositis; Head and Neck Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06307327

NFEC-2024-098

Details and patient eligibility

About

Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.

Full description

Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors, and it needs to be treated according to the severity of mucositis to reduce symptoms and improve quality of life. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency, which seriously restricts doctors' correct evaluation and treatment of mucositis patients. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.

Enrollment: 894 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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