Hearing Impairment of Nasopharyngeal Carcinoma

NCT05330169 | Completed

• 1 other identifier: GuangxiMUHK3
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Hearing Toxicity; Chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• Hearing level (decibel)

  We will use pure tone audiometry to access the hearing level (decibel) before treatment and serially up to 1 year after radical chemoradiotherapy.

  up to 16 months

• The ratio of distortion product otoacoustic emission(DPOAE) failure

  We will use distortion product otoacoustic emission(DPOAE) to access the hearing before treatment and serially up to 1 year after radical chemoradiotherapy.

  up to 16 months

Secondary Outcomes (2)

• The ratio of Eustachian tube dysfuction(ETD)

  up to 16 months

• Tympanogram type

  up to 16 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

nasopharyngeal carcinoma patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 15, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)