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:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT05330169
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
2. About to undergo radical chemoradiotherapy with intensity-modulated radiotherapy (IMRT).
3. Eastern Cooperative Oncology Group performance status≤1.
4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin
≥90g/L, and platelet count≥100×10e9/L.
5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST)
≤2.5×upper limit of normal (ULN), and bilirubin≤ 1.5×ULN.
6. Adequate renal function: creatinine clearance rate≥ 60 ml/min (Cockcroft-Gault formula).
7. Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
1. Age \> 60 or \< 18.
2. Receiving additional targeted therapy or immunotherapy except for radiotherapy and chemotherapy.
3. With a condition that could cause hearing impairment, such as ear canal cerumen blockage, ear canal foreign body blockage, cholesteatoma, tympanic membrane perforation, cholesteatoma otitis media, middle ear granulation tissue growth, inner ear labyrinthitis, sudden nerve deafness, Meniere's disease, acoustic neuroma, and so on.
4. Patients who received aminoglycoside antibiotics or macrocyclic lipid antibiotics (such as streptomycin, gentamicin, kanamycin, neomycin, tobramycin, minocycline, erythromycin, roxithromycin, etc.) orally or intravenously within 30 days before treatment.
5. Patients with hearing loss at the baseline（except for those with conductive hearing loss diagnosed by at least two deputy chief physicians as nasopharyngeal carcinoma-related）
6. Patients who received additional treatment during the observation period due to disease progression.
7. Pregnant or breastfeeding.
8. Patients with prior malignancy who have received systemic chemotherapy or head and neck radiotherapy.
9. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05330169
Study Brief:
Protocol Section:
NCT05330169