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

NCT ID: NCT04214769

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-08-31

Brief Summary

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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

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Conditions

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Head and Neck Cancer Patients Treated With Radiotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Head and Neck Cancer patients

Audiometry and tympanometry, vHIT, VEMP, ENG

Intervention Type DIAGNOSTIC_TEST

Diagnostic tests

Interventions

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Audiometry and tympanometry, vHIT, VEMP, ENG

Diagnostic tests

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Yahav Oron, MD

Role: CONTACT

973236973573

Other Identifiers

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403-19

Identifier Type: -

Identifier Source: org_study_id

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