Head and Neck TumorsNCT06968520
Correlation and Predictive Research of Metal Elements in Radiation-Induced Oral Mucositis
An observational study of Head and Neck Tumors and Metal, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Tumors, Metal, Copper
- How many people
- 383 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: According to the 2021CSCO guidelines, patients diagnosed as nasopharyngeal carcinoma and head and neck tumors were standardized
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, M.D., 86+13632102247, guanjian5461@163.com
Jian Guan, M.D.
About this study
Official title: Correlation and Predictive Study of Metal Elements in Radiation-Induced Oral Mucositis: A Prospective, Longitudinal Cohort Study
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.
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rates of severe radiation-induced oral mucositis.
The incidence rates of sever radiation-induced oral mucositis across various severity grades will be determined.Grade>=3 is regarded as severe RTOM.
Measured: Through study completion, up to 1 year
Secondary outcomes (3)
Duration of RTOM and SRTOM.
Recording the start time and duration of RTOM and SRTOM.
Measured: Through study completion, up to 1 year
Quality of life score.
The quality of life including physical health, mental health, spiritual health and social and interpersonal relationships.
Measured: Through study completion, up to 1 year
Other recent adverse radiation reactions
Other recent adverse radiation reactions caused by radiotherapy
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start24 Apr 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck TumorsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 383 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968520
- Sponsor's protocol ID
- NEFC-2025-173
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation and Predictive Study of Metal Elements in Radiation-Induced Oral Mucositis: A Prospective, Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT06968520
- Acronym / sponsor ID
- NEFC-2025-173
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 383 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to the 2021CSCO guidelines, patients diagnosed as nasopharyngeal carcinoma and head and neck tumors were standardized
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Duration of RTOM and SRTOM.
Time frame: Through study completion, up to 1 year
Quality of life score.
Time frame: Through study completion, up to 1 year
Other recent adverse radiation reactions
Time frame: Through study completion, up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Tumors and Metal, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rates of severe radiation-induced oral mucositis. (time frame: Through study completion, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.