Clinical trial NCT05330169: Hearing Impairment of Nasopharyngeal Carcinoma
Official title: Prospective Observational Cohort Study to Evaluate Hearing Toxicity Before and After Chemoradiotherapy in Patients With Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carcinoma
Keywords: Hearing Toxicity
Chemoradiotherapy
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: nasopharyngeal carcinoma patients

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%. However, the incidence of hearing toxicity did not decrease significantly compared with the past. The hearing loss remains the second most common toxicity after xerostomia. Audiometry, acoustic impedance testing, eustachian tube pressure measurements, and distortion product otoacoustic emissions will be used to compare hearing before treatment and up to 1 year after radical chemoradiotherapy. The related factors affecting the hearing of NPC patients will also be investigated and explored.

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.

Primary outcomes:
measure: Hearing level (decibel)
timeFrame: up to 16 months
measure: The ratio of distortion product otoacoustic emission(DPOAE) failure
timeFrame: up to 16 months
Secondary outcomes:
measure: The ratio of Eustachian tube dysfuction(ETD)
timeFrame: up to 16 months
measure: Tympanogram type
timeFrame: up to 16 months
Other outcomes:
Locations:
city: Nanning
country: China
facility: the First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
References: