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

Recruiting

• Conditions: Head and Neck Tumors; Metal; Copper; Radiotherapy-Induced Oral Mucositis

• Registration Number: NCT06968520
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-24
• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-11-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 383

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Duration of RTOM and SRTOM.	Through study completion, up to 1 year	Recording the start time and duration of RTOM and SRTOM.
Other recent adverse radiation reactions	Through study completion, up to 1 year	Other recent adverse radiation reactions caused by radiotherapy
Quality of life score.	Through study completion, up to 1 year	The quality of life including physical health, mental health, spiritual health and social and interpersonal relationships.

Trial Locations

Locations (1)

Nanfang hospital, Southern medical university; 🇨🇳 Guangzhou, Guangdong, China