Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06968520

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

Led by Nanfang Hospital, Southern Medical University · Updated on 2025-05-13

383

Participants Needed

1

Research Sites

44 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Diagnosed by pathological biopsy with nasopharyngeal carcinoma or head and neck tumors
  • Indicated for radiotherapy and willing to accept it
  • ECOG Performance Status of 0 or 1
  • Aged between 18 and 75 years
  • Laboratory tests show good organ function
Not Eligible

You will not qualify if you...

  • Contraindications for radiotherapy
  • Presence of other tumors
  • Pathological sections unavailable
  • Serious concurrent diseases posing risks or affecting study compliance, such as unstable heart disease needing treatment, chronic hepatitis, poor kidney function, uncontrolled diabetes (fasting blood glucose > 1.5 times upper limit of normal), or mental disorders
  • Investigator's judgment that participation is unsuitable

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China, 510515

Actively Recruiting

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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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