Radiation-induced Oropharyngeal MucositisNCT06308328
A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
An observational study of Radiation-induced Oropharyngeal Mucositis and Swallowing-induced Breakthrough Pain, run by Nanfang Hospital, Southern Medical University at 10 sites in China.
Trial summary
The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain
- How many people
- 718 participants
- Where
- 10 sitesChina
- Study dates
- 1 Apr 2024to 31 Jan 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with nasopharyngeal carcinoma receiving radical radiotherapy or chemoradiotherapy
Who may be able to join
- Provide informed written consent.
- Age ≥ 18 years.
- Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy.
- Complete and continuous records of oral / oropharyngeal mucositis grading, and self-reported swallowing-induced breakthrough pain.
Who cannot join
- Existence of poor oral hygiene, untreated dental or periodontal diseases, and metal dental restorations.
- Current untreated or unresolved conditions like unstable heart diseases requiring treatment, and poorly controlled diabetes mellitus.
- Body mass index (BMI) <18.5.
- Unsuitable to participate in current study, according to researchers' assessment.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan
Wenjun Liao
- Not yet recruiting
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong
Ronghui Zheng
- Recruiting
Nanfang hospital, Southern medical university
Guangzhou, Guangdong
Jian Guan, Ph.D., 86+13632102247, guanjian5461@163.com
- Not yet recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Yimin Liu
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Linglong Tang
- Not yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Yong Bao
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Xueguan lv
- Not yet recruiting
Yuebei People's Hospital
Shaoguan, Guangdong
Suming Pan
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Min Chen
- Not yet recruiting
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong
Siyang Wang
About this study
Official title: A Real-world Observational Study of a Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Predicting Radiation-induced Oropharyngeal Mucositis in Patients With Nasopharyngeal Carcinoma
The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.
Read the detailed description
Swallowing-induced breakthrough pain as a prominent clinical challenge for radiation-induced oropharyngeal mucositis, occurs in almost all patients with nasopharyngeal carcinoma (NPC) undergoing radiotherapy, and has a significant impact on patients' quality of life and treatment outcomes. Radiation-induced oropharyngeal mucositis is closely related to the irradiated dose and volume, and the performance of the predictive models for its occurrence and severity established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory. Thus, it is difficult to carry out risk assessment, precise screening and early intervention through dosimetric parameters, thereby reducing the occurrence of severe radiation-induced oropharyngeal mucositis. The investigators defined a delineation method based on the mucosal areas of radiation-induced injury resulting in swallowing-induced breakthrough pain in locally advanced NPC, and our preliminary results demonstrated that the predictive model exhibited better overall performance. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.
- Keywords
- Nasopharyngeal carcinoma, Radiotherapy, Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain, Delineation method
- Medical subject headings
- Nasopharyngeal Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
The AUC of the predictive model
The area under the ROC (receiver operating characteristic) curve (AUC) of the predictive model
Measured: Through study completion, up to 3 years
Secondary outcomes (7)
The accuracy of the predictive model
To obtained this index, true positive (TP) and true negative (TN) were calculated from the confusion matrix.
Accuracy = (TP+TN)/(Σ Total population)
Measured: Through study completion, up to 3 years
The sensitivity of the predictive model
To obtained this index, true positive (TP) and false negative (FN) were calculated from the confusion matrix.
Sensitivity = TP/(TP + FN)
Measured: Through study completion, up to 3 years
The specificity of the predictive model
To obtained this index, false positive (FP) and true negative (TN) were calculated from the confusion matrix.
Specificity = TN/(TN + FP)
Measured: Through study completion, up to 3 years
The positive predictive value of the predictive model
To obtained this index, true positive (TP) and false positive (FP) were calculated from the confusion matrix.
Positive Predictive value (PPV) = TP/(TP + FP)
Measured: Through study completion, up to 3 years
The negative predictive value of the predictive model
To obtained this index, true negative (TN) and false negative (FN) were calculated from the confusion matrix.
Negative Predictive value (NPV) = TN/(TN + FN)
Measured: Through study completion, up to 3 years
The F1 score of the predictive model
To obtained this index, true positive (TP), false positive (FP), and false negative (FN) were calculated from the confusion matrix.
F1 score = 2TP/(2TP + FP + FN)
Measured: Through study completion, up to 3 years
The important predictors of severe oropharyngeal mucositis in the predictive model
The importance of variables included in the predictive model was measure, and those with a higher value indicating a greater contribution to the model's classification accuracy were viewed as the important predictors.
Measured: Through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced Oropharyngeal MucositisStudies 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
- Prospective
- Enrolment
- 718 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Guan, Ph.D., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308328
- Sponsor's protocol ID
- NFEC-2024-090
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Observational Study of a Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Predicting Radiation-induced Oropharyngeal Mucositis in Patients With Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06308328
- Acronym / sponsor ID
- NFEC-2024-090
- Keywords
- Nasopharyngeal carcinoma, Radiotherapy, Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain, Delineation method
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 718 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 13 Mar 2024 (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.
The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.
Detailed description
Swallowing-induced breakthrough pain as a prominent clinical challenge for radiation-induced oropharyngeal mucositis, occurs in almost all patients with nasopharyngeal carcinoma (NPC) undergoing radiotherapy, and has a significant impact on patients' quality of life and treatment outcomes. Radiation-induced oropharyngeal mucositis is closely related to the irradiated dose and volume, and the performance of the predictive models for its occurrence and severity established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory. Thus, it is difficult to carry out risk assessment, precise screening and early intervention through dosimetric parameters, thereby reducing the occurrence of severe radiation-induced oropharyngeal mucositis. The investigators defined a delineation method based on the mucosal areas of radiation-induced injury resulting in swallowing-induced breakthrough pain in locally advanced NPC, and our preliminary results demonstrated that the predictive model exhibited better overall performance. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with nasopharyngeal carcinoma receiving radical radiotherapy or chemoradiotherapy
Key inclusion criteria (4 listed)
- Provide informed written consent.
- Age ≥ 18 years.
- Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy.
- Complete and continuous records of oral / oropharyngeal mucositis grading, and self-reported swallowing-induced breakthrough pain.
Key exclusion criteria (4 listed)
- Existence of poor oral hygiene, untreated dental or periodontal diseases, and metal dental restorations.
- Current untreated or unresolved conditions like unstable heart diseases requiring treatment, and poorly controlled diabetes mellitus.
- Body mass index (BMI) <18.5.
- Unsuitable to participate in current study, according to researchers' assessment.
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 AUC of the predictive model
Time frame: Through study completion, up to 3 years
The area under the ROC (receiver operating characteristic) curve (AUC) of the predictive model
7 secondary outcomes
The accuracy of the predictive model
Time frame: Through study completion, up to 3 years
The sensitivity of the predictive model
Time frame: Through study completion, up to 3 years
The specificity of the predictive model
Time frame: Through study completion, up to 3 years
The positive predictive value of the predictive model
Time frame: Through study completion, up to 3 years
The negative predictive value of the predictive model
Time frame: Through study completion, up to 3 years
The F1 score of the predictive model
Time frame: Through study completion, up to 3 years
The important predictors of severe oropharyngeal mucositis in the predictive model
Time frame: Through study completion, up to 3 years
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 Mar 2024.
- 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.
Jian Guan, Ph.D. principal investigator
Nanfang Hospital, Southern Medical University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation-induced Oropharyngeal Mucositis and Swallowing-induced Breakthrough Pain, run by Nanfang Hospital, Southern Medical University at 10 sites 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 4 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: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Contact Jian Guan, Ph.D. (+86-13632102247, guanjian5461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The AUC of the predictive model (time frame: Through study completion, up to 3 years). 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 Mar 2024.