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

Evaluation of the Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function Using Novel Techniques

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

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer Patients Treated With Radiotherapy
• Intervention / Treatment: Diagnostic test: Audiometry and tympanometry, vHIT, VEMP, ENG

• Study Type: Observational
• Enrollment (Anticipated): 17

Contacts and Locations

• Study Contact: Name: Yahav Oron, MD; Phone Number: 973236973573; Email: oron.yahav@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed Head and Neck cancers, not treated previously, and planned for radiation therapy in which the inner ear will be radiated

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Head and Neck Cancer patients	Diagnostic test: Audiometry and tympanometry, vHIT, VEMP, ENG; Diagnostic tests

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: December 28, 2019
• First Submitted That Met QC Criteria: December 28, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 403-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No