Understanding metal elements in radiation-induced mouth sores
Correlation and Predictive Study of Metal Elements in Radiation-Induced Oral Mucositis: A Prospective, Longitudinal Cohort Study
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 |
|---|---|
| Enrollment | 383 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06968520 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with confirmed head and neck tumors who are scheduled to receive radiotherapy.
Not a fit: Patients with contraindications for radiotherapy or those with serious concurrent diseases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Nanfang hospital, Southern medical university — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.