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

NCT06968520 · tracked via the Priya Life Science China tracker

Sponsor

Nanfang Hospital, Southern Medical University

Phase

Observational

Started

2025-04-24

Last updated

2025-05-13

Condition(s) studied

Head and Neck TumorsMetalCopperRadiotherapy-Induced Oral Mucositis

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1）Sign the informed consent form; 2) Confirmed by pathological biopsy as nasopharyngeal carcinoma or head and neck tumors; 3) Have indications for radiotherapy and voluntarily accept radiotherapy; 4) ECOG PS: 0/1; 5) Age: 18-75 years old; 6) Laboratory tests confirm good organ function. Exclusion Criteria: 1. There are contraindications for radiotherapy; 2. Combined with other tumors; 3. Pathological sections could not be obtained; 4. The patient has any serious concurrent diseases that may pose unacceptable risks or have a negative impact on trial compliance. For instance, unstable heart diseases requiring treatment, chronic hepatitis, kidney diseases with poor conditions, uncontrolled diabetes (fasting blood glucose greater than 1.5 × ULN), and mental disorders; 5. The researcher judged that it was not suitable to participate in this study.

Primary outcome measure(s)

The incidence rates of severe radiation-induced oral mucositis. — Through study completion, up to 1 year
The incidence rates of sever radiation-induced oral mucositis across various severity grades will be determined.Grade\>=3 is regarded as severe RTOM.

Trial sites (1)

Facility	City	Region	Status
Nanfang hospital, Southern medical university	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06968520 on ClinicalTrials.gov ↗ ← All trials in China