Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function

• Conditions: Head and Neck Cancer Patients Treated With Radiotherapy
• Interventions: Diagnostic Test: Audiometry and tympanometry, vHIT, VEMP, ENG

• Registration Number: NCT04214769
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

Aims: 1. To evaluate the effects of radiation therapy on the inner ear, among patients treated with radiation therapy for head and neck cancers using a wide battery of tests (Audiometry and tympanometry, vHIT, VEMP, ENG) ; 2. To correlate the mean total radiation dose to the cochlea with the effects on audiological and vestibular function

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-28
• Study First Submitted QC: 2019-12-28
• Last Update Submitted: 2019-12-28
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02
• Study Start: 2020-03-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Females and males, Age: ≥ 18 years old
• Patients diagnosed Head and Neck cancers, not treated previously
• Planned for radiation therapy in which the inner ear will be radiated

Exclusion Criteria

• Patients who were previously diagnosed with a vestibular disorder
• Previous middle or inner ear anomaly
• Failure to complete the whole course of radiation therapy
• More than one course of radiation therapy
• Patients treated with concurrent ototoxic chemotherapy
• Pregnant women
• Patients who will not sign an informed consent form
• Helpless or incompetent patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head and Neck Cancer patients	Audiometry and tympanometry, vHIT, VEMP, ENG	-

Primary Outcome Measures

Name	Time	Method
VEMP test	1.5 Year	Abnormal latencies, amplitudes, thresholds
Audiometry	1.5 Year	The change in hearing threshold and in the speech-audiometry
ENG test	1.5 Year	Abnormal function of the central vestibular pathways, unilateral weakness of the vestibular apparatus or direction preponderance
vHIT test	1.5 Year	abnormal gain, the appearance of overt and covert saccades