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NCT Number: NCT06968520

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, 510515, China

Location status: Recruiting

Location contact

Jian Guan, M.D.

CONTACT

[email protected]

86+13632102247

Jian Guan, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: Through study completion, up to 1 year

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

Secondary outcomes

  1. Duration of RTOM and SRTOM.

    Time frame: Through study completion, up to 1 year

    Recording the start time and duration of RTOM and SRTOM.

  2. Quality of life score.

    Time frame: Through study completion, up to 1 year

    The quality of life including physical health, mental health, spiritual health and social and interpersonal relationships.

  3. Other recent adverse radiation reactions

    Time frame: Through study completion, up to 1 year

    Other recent adverse radiation reactions caused by radiotherapy

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

Correlation and Predictive Study of Metal Elements in Radiation-Induced Oral Mucositis: A Prospective, Longitudinal Cohort Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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