Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06307327

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern medical university, Guangzhou, Guangdong, China

Loading trial locations.

About this study

Since this is an observational study, no additional visits, laboratory analyses, or evaluations beyond the routine clinical practice requirements are necessary. Patients must sign the latest informed consent form (ICF) approved by the ethics committee before data collection is carried out. After obtaining the patient's consent, clinical routine diagnosis and treatment information will be collected.

The study is divided into three parts. The first part compares the consistency of results among different methods used to assess mucositis. The research process involves having different doctors assess the same patient at the same stage using a specific grading method three times, and taking the results of more than two of these assessments as the internal unified results of that grading method (each patient can be assessed and data recorded every 1-2 weeks during radiotherapy). After obtaining the internal unified results of the three mucositis grading methods, the consistency of results among different methods used for assessment is compared.

The second part first determines the internal consistency of doctor evaluations for four methods (the traditional three mucositis grading methods and the new classification method), and then uses the consistency results of each method to compare the stability of the assessments. The research process involves having different doctors assess the same patient at the same stage using a specific method three times. Each patient can be assessed and data recorded every 1-2 weeks during radiotherapy. The consistency of evaluations among different doctors for this method is obtained. Finally, this consistency is used to compare the stability of the assessments between different methods.

The third part compares the consistency of results between the assessment using the new mucositis classification method and the patient's self-assessment. The research process involves having different doctors assess the same patient at the same stage using the new classification method three times, and taking the results of more than two of these assessments as the internal unified result of the new classification method (each patient can be assessed and data recorded every 1-2 weeks during radiotherapy). After obtaining the internal unified results of the new classification method and the patient's self-assessment results, the consistency of results between using the new classification method and the patient's self-assessment is compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Inter-rater consistency among doctors

    Time frame: Through study completion, up to 3 years

    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

  1. Consistency in assessment between doctors and patients

    Time frame: Through study completion, up to 3 years

    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.

  2. The assessment period

    Time frame: Through study completion, up to 3 years

    The assessment times used respectively for different assessment methods

  3. the satisfaction of patients

    Time frame: Through study completion, up to 3 years

    the satisfaction of patients

  4. the satisfaction of doctors

    Time frame: Through study completion, up to 3 years

    the satisfaction of doctors

Other outcomes

  1. Exploration of blood biomarkers related to the classification of radioactive oropharyngeal mucositis

    Time frame: Through study completion, up to 3 years

    Exploration of blood biomarkers related to the classification of radioactive oropharyngeal mucositis

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Guan, M.D

CONTACT

[email protected]

+86-13632102247

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.