Understanding metal elements in radiation-induced mouth sores
Official title: Correlation and Predictive Study of Metal Elements in Radiation-Induced Oral Mucositis: A Prospective, Longitudinal Cohort Study
Run by Nanfang Hospital, Southern Medical University · NCT06968520 · Data updated 2026-11-12
This study is trying to see if certain metal elements in the body can help predict how severe mouth sores will be for patients getting radiation treatment for head and neck cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 383 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | April 24, 2025 |
| Main results expected | November 30, 2025 |
| Study ends | February 28, 2026 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT06968520 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-75 with confirmed head and neck tumors who are scheduled to receive radiotherapy.
✕Probably not a fit
Patients with contraindications for radiotherapy or those with serious concurrent diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the correlation between metal elements and the occurrence of radiation-induced oral mucositis (RIOM) in patients undergoing radiotherapy for head and neck tumors. It aims to identify predictive factors that could help in anticipating the severity and incidence of RIOM, which significantly impacts patients' quality of life and treatment efficacy. By analyzing the steady-state of metallic elements in patients, the study seeks to explore effective prevention and treatment strategies for this common complication of radiotherapy. The findings could lead to improved management of RIOM and better overall outcomes for patients.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and management of oral mucositis, enhancing the quality of life for patients undergoing treatment for head and neck tumors.
How similar studies have gone: Previous studies have indicated a potential link between metal elements and mucositis, suggesting that this approach may yield valuable insights, although it remains a relatively novel area of investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Nanfang hospital, Southern medical university
Guangzhou, Guangdong, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.