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
1 other identifier
observational
17
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedJanuary 2, 2020
December 1, 2019
1.5 years
December 28, 2019
December 28, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
Head and Neck Cancer patients
Interventions
Diagnostic tests
Eligibility Criteria
Patients diagnosed Head and Neck cancers, not treated previously, and planned for radiation therapy in which the inner ear will be radiated
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2019
First Posted
January 2, 2020
Study Start
March 1, 2020
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
January 2, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share