Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07312656
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed malignant tumor of the head and neck;
2. Age 18-75 years;
3. Scheduled to receive radical radiotherapy with a total planned dose of ≥60 Gy, with radiation fields including the oral cavity and/or oropharynx;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and a life expectancy of ≥6 months.
5. White blood cell≥3.0×10\^9/L, hemoglobin≥ 90 g/L, platelet (PLT)≥ 100x10\^9/ L
6. Transaminases≤2.5 times the upper limit of normal, total bilirubin ≤1.5 times the upper limit of normal;
7. Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min;
8. Cardiac: Electrocardiogram (ECG) without clinically significant abnormalities;
9. Intact oral mucosa before initiation of radiotherapy. Absence of active oral infections or severe periodontal disease before initiation of radiotherapy;
10. Signed informed consent form.
Exclusion Criteria:
1. Previous radiotherapy to the head and neck region;
2. Head and neck surgery within the preceding 4 weeks;
3. Current participation in another clinical trial, or participation in another interventional study within the past 4 weeks;
4. Significant cardiovascular disease, including unstable angina, myocardial infarction within the past 6 months, severe arrhythmia, or heart failure (NYHA Class III-IV);
5. Severe hepatic or renal dysfunction, such as cirrhosis or chronic renal insufficiency (creatinine clearance \<30 mL/min);
6. Active systemic infection requiring antimicrobial therapy;
7. Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring ongoing immunosuppressive treatment;
8. Severe psychiatric disorders that may impair the ability to provide informed consent or adhere to the study protocol;
9. Using other oral mucosal protective agents or anti-inflammatory medications that cannot be discontinued. Long-term use of immunosuppressants or corticosteroids at a prednisone-equivalent dose \>10 mg/day;
10. Individuals unable to comprehend the study requirements or comply with study procedures;
11. Any other condition that, in the judgment of the investigator, would render the patient unsuitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07312656
Study Brief:
Protocol Section:
NCT07312656