Correlation and Predictive Research of Metal Elements in Radiation-Induced Oral Mucositis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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;
Trial population
According to the 2021CSCO guidelines, patients diagnosed as nasopharyngeal carcinoma and head and neck tumors were standardized
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, up to 1 yearSecondary outcomes
1
Duration of RTOM and SRTOM.
Recording the start time and duration of RTOM and SRTOM.
Time frame
Through study completion, up to 1 year2
Quality of life score.
The quality of life including physical health, mental health, spiritual health and social and interpersonal relationships.
Time frame
Through study completion, up to 1 year3
Other recent adverse radiation reactions
Other recent adverse radiation reactions caused by radiotherapy
Time frame
Through study completion, up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov