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Correlation and Predictive Study of Metal Elements in Radiation-Induced Oral Mucositis: A Prospective, Longitudinal Cohort Study
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-05-13
383
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the relationship between metal elements and the development of radiation-induced oral mucositis (RIOM) in patients treated for head and neck tumors, such as nasopharyngeal carcinoma. This observational study aims to understand how metal levels may predict the occurrence and severity of RIOM, a common and painful side effect of radiotherapy that significantly affects patients' quality of life and treatment success. The study will follow patients who are undergoing radiotherapy for head and neck tumors. It will observe changes in metal elements over time and analyze how these changes relate to severe RIOM. The research does not involve experimental treatments but focuses on collecting data throughout the radiotherapy process and after, with a monitoring period lasting up to one year. Participants will be regularly assessed for the incidence and duration of severe oral mucositis, quality of life, and other radiation-related side effects. The study will include laboratory tests and clinical evaluations to monitor these outcomes. The total observation period for each participant can last up to one year following radiotherapy, allowing a comprehensive review of RIOM and its possible predictors.
CONDITIONS
Brief Title
Correlation and Predictive Research of Metal Elements in Radiation-Induced Oral Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Diagnosed with nasopharyngeal carcinoma or head and neck tumors confirmed by biopsy
- Indicated for and willing to receive radiotherapy
- ECOG performance status of 0 or 1
- Aged between 18 and 75 years
- Laboratory tests show good organ function
You will not qualify if you...
- Contraindications to radiotherapy
- Presence of other tumors
- Unable to obtain pathological sections
- Serious concurrent diseases that increase risk or affect trial compliance, such as unstable heart disease, chronic hepatitis, poor kidney function, uncontrolled diabetes (fasting blood glucose >1.5 times upper limit), or mental disorders
- Judged by researchers as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants are observed to assess the incidence and duration of radiation-induced oral mucositis and other adverse radiation reactions during and after radiotherapy.
Regular visits during and after radiotherapy as per clinical schedule
Trial Site Locations
Total: 1 location
1
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, China, 510515
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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