Status:
COMPLETED
Hearing Impairment of Nasopharyngeal Carcinoma
Lead Sponsor:
Guangxi Medical University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-60 years
Brief Summary
This observational cohort study was aimed to evaluate the hearing toxicity at multiple time points from baseline to 1 year after radical chemoradiotherapy among nasopharyngeal carcinoma patients.
Detailed Description
With the development of radiotherapeutic techniques and equipment as well as advances in treatment modalities, the 5-year overall survival of patients with non-disseminated NPC has exceeded 80%. Howev...
Eligibility Criteria
Inclusion
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
- About to undergo radical chemoradiotherapy with intensity-modulated radiotherapy (IMRT).
- Eastern Cooperative Oncology Group performance status≤1.
- Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin
- ≥90g/L, and platelet count≥100×10e9/L.
- Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST)
- ≤2.5×upper limit of normal (ULN), and bilirubin≤ 1.5×ULN.
- Adequate renal function: creatinine clearance rate≥ 60 ml/min (Cockcroft-Gault formula).
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion
- Age \> 60 or \< 18.
- Receiving additional targeted therapy or immunotherapy except for radiotherapy and chemotherapy.
- 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.
- 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.
- 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）
- Patients who received additional treatment during the observation period due to disease progression.
- Pregnant or breastfeeding.
- Patients with prior malignancy who have received systemic chemotherapy or head and neck radiotherapy.
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05330169
Start Date
September 1 2022
End Date
December 31 2023
Last Update
July 17 2024
Active Locations (1)
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1
the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021