About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
The subjects in this study were head and neck tumor patients receiving radiotherapy
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Inter-rater consistency among doctors
Different physician assessments of agreement (percentage) were directly compared between the new and traditional classifications. Consistency refers to the proportion of assessments made by two doctors that are the same.
Secondary outcomes
Consistency in assessment between doctors and patients
In the new classification, the consistency (percentage) of assessment between doctors and patients was compared. Consistency refers to the proportion of times where the assessments made by the two doctors were the same.
The assessment period
The assessment times used respectively for different assessment methods
the satisfaction of patients
the satisfaction of patients
the satisfaction of doctors
the satisfaction of doctors
Other outcomes
Exploration of blood biomarkers related to the classification of radioactive oropharyngeal mucositis
Exploration of blood biomarkers related to the classification of radioactive oropharyngeal mucositis
Sponsors and contacts
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