RecruitingNCT06968520

Correlation and Predictive Research of Metal Elements in Radiation-Induced Oral Mucositis

Correlation and Predictive Study of Metal Elements in Radiation-Induced Oral Mucositis: A Prospective, Longitudinal Cohort Study


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

383 participants

Start Date

Apr 24, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Radiotherapy is the main treatment method for head and neck tumors. However, almost all patients with head and neck tumors will develop acute inflammatory reactions such as Radiotherapy-Induced Oral Mucositis (RIOM) after receiving Radiotherapy, resulting in a decline in the quality of life of patients, hindering the smooth implementation of the treatment plan, reducing the therapeutic effect, and increasing the economic burden of patients. However, the current treatment strategies for RIOM focus on symptomatic treatment and have little impact on the course, severity and related complications of mucositis. Therefore, exploring effective strategies, predicting the incidence and severity of RIOM in patients, and providing prevention and treatment are the clinical bottlenecks and cutting-edge issues that urgently need to be solved in the current clinical practice of radiotherapy for head and neck tumors. Previous studies have shown that the steady-state of metallic elements may be closely related to the occurrence and development of RIOM. Therefore, we plan to conduct a prospective, single-center, observational study to further explore the correlation between metal elements and severe RIOM, analyze its predictive efficacy, and observe the dynamic changes of metal elements in radiotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether levels of certain metals in the body are linked to the severity of mouth sores (oral mucositis) that commonly develop during radiation treatment for nasopharyngeal or head and neck cancers. The goal is to find predictive markers that could help doctors manage or prevent this painful side effect. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with nasopharyngeal carcinoma or another head and neck tumor confirmed by biopsy - You are scheduled to receive radiation therapy - You are in generally good health with adequate organ function - Your daily function level is 0 or 1 on a standard activity scale **You may NOT be eligible if...** - You have a condition that prevents you from receiving radiotherapy - You have another active cancer at the same time - Tissue samples cannot be obtained for analysis - You have uncontrolled diabetes, active hepatitis, severe heart disease, kidney disease, or a psychiatric condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China

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NCT06968520


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