Clinical trial NCT06307327: Comparative Study of New Classification and Traditional Classification of Radioactive 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Radiation-Induced Mucositis
Keywords: Radiation oropharyngeal mucositis
Head and Neck Cancer
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 894
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects in this study were head and neck tumor patients receiving radiotherapy

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Evaluation consistency
timeFrame: Through study completion, up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern medical university
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
state: Guangdong
city: Jieyang
country: China
facility: Jieyang people's hospital
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jian Guan, M.D
role: PRINCIPAL_INVESTIGATOR
References: