Head and neck malignant tumors
Conditions
Interventions
Observation group:None
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age is over 18 years old. 2.Histologically confirmed malignant tumor of the head and neck. 3.Planned to receive radiotherapy or radiotherapy combined with systemic therapy (chemotherapy, targeted therapy, or immunotherapy). 4.ECOG performance status 0–1. 5.No contraindications to chemotherapy, targeted therapy, immunotherapy, or radiotherapy. 6.Women of childbearing potential must use reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use effective contraception during the study; male participants with partners of childbearing potential must use effective contraception during the study.
Exclusion criteria
Exclusion criteria: 1.Previous or concurrent other malignancies that are not cured, except cured head and neck malignancies. 2.Active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [patients on stable hormone replacement therapy may be included]); patients with vitiligo or childhood asthma that has completely resolved without adult intervention may be included, whereas those requiring bronchodilator therapy are excluded. 3.Uncontrolled cardiovascular disease: myocardial ischemia or infarction >= Grade II; poorly controlled arrhythmias (including QTc interval >= 470 ms); NYHA Class III–IV heart failure; left ventricular ejection fraction (LVEF) < 50% on echocardiography; or myocardial infarction within the past year. 4.Deemed unsuitable for radiotherapy by the physician. 5.Participation in another clinical study within 4 weeks prior to the first radiotherapy session (or during follow-up, calculated from the last use of an investigational drug or device). 6.Pregnant or breastfeeding women. 7.Other conditions judged by the investigator to potentially lead to premature withdrawal, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, or family/social factors that may affect participant safety or data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The predictive accuracy of the model for severe oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| The accuracy of the combined prediction of severe oral mucositis using the oral microbiome, imaging features, and blood biomarkers.;The association between the oral microbiota and the incidence, onset time, and duration of severe oral mucositis.;Sensitivity and specificity of the different predictive models.;The association between the oral microbiome and late toxicities.;The dynamic trajectory of the oral microbiome; | — |
Countries
China
Contacts
Public ContactQiao Qiao
The First Affiliated Hospital of China Medical University
Outcome results
None listed