Clinical trial · Observational
Hearing Impairment of Nasopharyngeal Carcinoma
Prospective Observational Cohort Study to Evaluate Hearing Toxicity Before and After Chemoradiotherapy in Patients With Nasopharyngeal Carcinoma
NCT05330169CI-TRIAL-00078885completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Hearing level (decibel)
- timeFrame
- up to 16 months
- description
- We will use pure tone audiometry to access the hearing level (decibel) before treatment and serially up to 1 year after radical chemoradiotherapy.
- measure
- The ratio of distortion product otoacoustic emission(DPOAE) failure
- timeFrame
- up to 16 months
- description
- We will use distortion product otoacoustic emission(DPOAE) to access the hearing before treatment and serially up to 1 year after radical chemoradiotherapy.
Secondary outcomes (2)
- measure
- The ratio of Eustachian tube dysfuction(ETD)
- timeFrame
- up to 16 months
- description
- We will use eustachian tube pressure measurement to access the eustachian tube function before treatment and serially up to 1 year after radical chemoradiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.