Nasopharyngeal Carcinoma by AJCC V8 StageNCT05858385
Predictive Study on Acute Radiation Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
An observational study of Nasopharyngeal Carcinoma by AJCC V8 Stage and Radiation Induced Mucositis, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial summary
Exploring effective risk prediction models for severe Radiation-Induced Oral Mucositis (RIOM/RTOM), providing a research basis for mitigating oral radiation toxicity, and effectively improving the sensitivity of dentists in predicting the risk of severe RIOM in locally advanced nasopharyngeal carcinoma patients.Based… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma by AJCC V8 Stage, Radiation Induced Mucositis
- What is being tested?
- Intervention based on key factors identified by the severe RIOM prediction model
- Type of treatment
- Pill or oral medicine
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Nasopharyngeal cancer patients diagnosed with tissue biopsy and no distant metastasis, who underwent RTOM observation and treatment throughout the radiotherapy period in the Department of Stomatology
Who may be able to join
- Confirmed as nasopharyngeal carcinoma through pathological tissue biopsy, AJCC 8th edition bed staging is I-Iva stage, with no distant metastasis
- First time receiving radical radiation therapy and receiving RTOM observation and treatment throughout the entire process in the Department of Stomatology
- Complete information on anti-tumor treatment materials
- No oral mucosal diseases that have not been effectively controlled in the past or still require long-term medication treatment
- Other diseases that do not affect the treatment of nasopharyngeal carcinoma
Who cannot join
- Failure to complete radiotherapy, or material release time delayed by more than two weeks compared to plan
- There are other diseases that affect the examination and treatment of oral mucosal inflammation, such as restricted mouth opening, Schegren's syndrome, etc
- Expected survival time less than 6 months
- Cases where patients withdraw from clinical trials at any time and for any reason
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yu Zeng
Guangzhou, Guangdong, 510000
Yu Zeng, Dr., +862066673666, apple02180717@126.com
About this study
Official title: Risk Prediction of Severe Radiation-induced Oral Mucositis in Locally Advanced Nasopharyngeal Carcinoma
Exploring effective risk prediction models for severe Radiation-Induced Oral Mucositis (RIOM/RTOM), providing a research basis for mitigating oral radiation toxicity, and effectively improving the sensitivity of dentists in predicting the risk of severe RIOM in locally advanced nasopharyngeal carcinoma patients.Based on precise radiotherapy, it is proposed to extract OAR using the contour of local oral areas. Explore more accurate RIOM dose-response relationships.Exploring a new type of fusion classifier, by complementing the information between each base classifier, helps to maximize the utilization of the information contained in different factors to build a more objective, reliable, and efficient multi criteria decision-making based risk prediction model for severe RIOM. It use predictive models to identify key risk factors for severe RIOM and further validate the effectiveness of this risk factor in reducing the risk of severe RIOM on risk factors for severe RIOM identified by the predictive mode.
Read the detailed description
This study investigates the prediction and management of Radiation-Induced Oral Mucositis (RIOM/RTOM) in patients with locally advanced nasopharyngeal carcinoma undergoing radiotherapy. RIOM is a significant concern due to its impact on the quality of life for patients and its potential to disrupt radiotherapy courses, affecting local tumor control rates. We systematically analyzed multifaceted data, including dosimetric parameters, clinical factors, and oral variables, to develop a predictive model for severe RIOM. The effectiveness of key risk factors in mitigating the risk of severe RIOM was further validated to predict and potentially prevent severe RIOM.
- Being tested
- Intervention based on key factors identified by the severe RIOM prediction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention based on key factors identified by the severe RIOM prediction modelOther
Intervention based on key factors identified by the severe RIOM prediction model
| Study group | Role | What they receive |
|---|---|---|
| Development and Validation of severe RIOM prediction model | This group aims to develop an artificial intelligence model using a retrospective cohort to predict severe RIOM in patients diagnosed with LA-NPC and evaluate risk factors for severe RIOM and further validate the effectiveness of this risk factor in reducing the risk of severe RIOM on risk factors for severe RIOM identified by the predictive model.The oral evaluation of all patients was conducted by the same senior dentist, who evaluated the oral mucosal radiation toxicity weekly at baseline (before RT) and after RT, and performed RIOM scores.RIOM is classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) . Receives: Other: Intervention based on key factors identified by the severe RIOM prediction model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe RIOM
According to the CTCAE V5.0 ，Grade 3 and Grade 4 is considered severe RTOM
Measured: during radiotherapy
Secondary outcomes (1)
Risk factors of severe RIOM
Patient factors, disease factors, and treatment related factors
Measured: baseline (before radiotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start22 Sep 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal Carcinoma by AJCC V8 StageStudies of the same condition, open and under way.
- 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858385
- Sponsor's protocol ID
- oral mucositis
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng Y, Hu Y, Wang L, Liao Z, Tan J, Kuang Y, Gong P, Qi B, Zhen X. Control of dental calculus Prevents severe Radiation-Induced oral mucositis in patients undergoing radiotherapy for nasopharyngeal carcinoma. Radiother Oncol. 2025 Jun;207:110872. doi: 10.1016/j.radonc.2025.110872. Epub 2025 Mar 27.
PubMed 40157544
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction of Severe Radiation-induced Oral Mucositis in Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05858385
- Acronym / sponsor ID
- oral mucositis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 May 2023 (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.
Exploring effective risk prediction models for severe Radiation-Induced Oral Mucositis (RIOM/RTOM), providing a research basis for mitigating oral radiation toxicity, and effectively improving the sensitivity of dentists in predicting the risk of severe RIOM in locally advanced nasopharyngeal carcinoma patients.Based on precise radiotherapy, it is proposed to extract OAR using the contour of local oral areas. Explore more accurate RIOM dose-response relationships.Exploring a new type of fusion classifier, by complementing the information between each base classifier, helps to maximize the utilization of the information contained in different factors to build a more objective, reliable, and efficient multi criteria decision-making based risk prediction model for severe RIOM. It use predictive models to identify key risk factors for severe RIOM and further validate the effectiveness of this risk factor in reducing the risk of severe RIOM on risk factors for severe RIOM identified by the predictive mode.
Detailed description
This study investigates the prediction and management of Radiation-Induced Oral Mucositis (RIOM/RTOM) in patients with locally advanced nasopharyngeal carcinoma undergoing radiotherapy. RIOM is a significant concern due to its impact on the quality of life for patients and its potential to disrupt radiotherapy courses, affecting local tumor control rates. We systematically analyzed multifaceted data, including dosimetric parameters, clinical factors, and oral variables, to develop a predictive model for severe RIOM. The effectiveness of key risk factors in mitigating the risk of severe RIOM was further validated to predict and potentially prevent severe RIOM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Development and Validation of severe RIOM prediction model | – | Other: Intervention based on key factors identified by the severe RIOM prediction modelThis group aims to develop an artificial intelligence model using a retrospective cohort to predict severe RIOM in patients diagnosed with LA-NPC and evaluate risk factors for severe RIOM and further validate the effectiveness of this risk factor in reducing the risk of severe RIOM on risk factors for severe RIOM identified by the predictive model.The oral evaluation of all patients was conducted by the same senior dentist, who evaluated the oral mucosal radiation toxicity weekly at baseline (before RT) and after RT, and performed RIOM scores.RIOM is classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nasopharyngeal cancer patients diagnosed with tissue biopsy and no distant metastasis, who underwent RTOM observation and treatment throughout the radiotherapy period in the Department of Stomatology
Key inclusion criteria (5 listed)
- Confirmed as nasopharyngeal carcinoma through pathological tissue biopsy, AJCC 8th edition bed staging is I-Iva stage, with no distant metastasis
- First time receiving radical radiation therapy and receiving RTOM observation and treatment throughout the entire process in the Department of Stomatology
- Complete information on anti-tumor treatment materials
- No oral mucosal diseases that have not been effectively controlled in the past or still require long-term medication treatment
- Other diseases that do not affect the treatment of nasopharyngeal carcinoma
Key exclusion criteria (4 listed)
- Failure to complete radiotherapy, or material release time delayed by more than two weeks compared to plan
- There are other diseases that affect the examination and treatment of oral mucosal inflammation, such as restricted mouth opening, Schegren's syndrome, etc
- Expected survival time less than 6 months
- Cases where patients withdraw from clinical trials at any time and for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention based on key factors identified by the severe RIOM prediction modelIntervention based on key factors identified by the severe RIOM prediction model | Other | Development and Validation of severe RIOM prediction model |
Primary outcome
Incidence of severe RIOM
Time frame: during radiotherapy
According to the CTCAE V5.0 ，Grade 3 and Grade 4 is considered severe RTOM
1 secondary outcome
Risk factors of severe RIOM
Time frame: baseline (before radiotherapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 40157544Zeng Y, Hu Y, Wang L, Liao Z, Tan J, Kuang Y, Gong P, Qi B, Zhen X. Control of dental calculus Prevents severe Radiation-Induced oral mucositis in patients undergoing radiotherapy for nasopharyngeal carcinoma. Radiother Oncol. 2025 Jun;207:110872. doi: 10.1016/j.radonc.2025.110872. Epub 2025 Mar 27.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Nasopharyngeal Carcinoma by AJCC V8 Stage and Radiation Induced Mucositis, run by Affiliated Cancer Hospital & Institute of Guangzhou 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
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?
Incidence of severe RIOM (time frame: during radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05858385, which also lists 1 linked publication.
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 30 Apr 2024.