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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04214769
Enrollment
17
Registered
2020-01-02
Start date
2020-03-01
Completion date
2021-08-31
Last updated
2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer Patients Treated With Radiotherapy

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

Interventions

DIAGNOSTIC_TESTAudiometry and tympanometry, vHIT, VEMP, ENG

Diagnostic tests

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Audiometry1.5 YearThe change in hearing threshold and in the speech-audiometry
ENG test1.5 YearAbnormal function of the central vestibular pathways, unilateral weakness of the vestibular apparatus or direction preponderance
VEMP test1.5 YearAbnormal latencies, amplitudes, thresholds
vHIT test1.5 Yearabnormal gain, the appearance of overt and covert saccades

Contacts

Primary ContactYahav Oron, MD
oron.yahav@gmail.com973236973573

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026