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

NCT06968520 | Recruiting

• 1 other identifier: NEFC-2025-173
• Study Type: observational
• Target: 383
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The incidence rates of severe radiation-induced oral mucositis.

  The incidence rates of sever radiation-induced oral mucositis across various severity grades will be determined.Grade\>=3 is regarded as severe RTOM.

  Through study completion, up to 1 year

Secondary Outcomes (3)

• Duration of RTOM and SRTOM.

  Through study completion, up to 1 year

• Quality of life score.

  Through study completion, up to 1 year

• Other recent adverse radiation reactions

  Through study completion, up to 1 year

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the 2021CSCO guidelines, patients diagnosed as nasopharyngeal carcinoma and head and neck tumors were standardized

You may qualify if:

• ）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.

You may not qualify if:

• There are contraindications for radiotherapy;
• Combined with other tumors;
• Pathological sections could not be obtained;
• 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;
• The researcher judged that it was not suitable to participate in this study.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: April 24, 2025
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

CN (1)