Head and Neck Cancer Patients Treated With RadiotherapyNCT04214769
Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function
An observational study of Head and Neck Cancer Patients Treated With Radiotherapy, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer Patients Treated With Radiotherapy
- What is being tested?
- Audiometry and tympanometry, vHIT, VEMP, ENG
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed Head and Neck cancers, not treated previously, and planned for radiation therapy in which the inner ear will be radiated
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Being tested
- Audiometry and tympanometry, vHIT, VEMP, ENG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiometry and tympanometry, vHIT, VEMP, ENGDiagnostic test
Diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Cancer patients | Not described Receives: Diagnostic Test: Audiometry and tympanometry, vHIT, VEMP, ENG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometry
The change in hearing threshold and in the speech-audiometry
Measured: 1.5 Year
ENG test
Abnormal function of the central vestibular pathways, unilateral weakness of the vestibular apparatus or direction preponderance
Measured: 1.5 Year
VEMP test
Abnormal latencies, amplitudes, thresholds
Measured: 1.5 Year
vHIT test
abnormal gain, the appearance of overt and covert saccades
Measured: 1.5 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Mar 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer Patients Treated With RadiotherapyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214769
- Sponsor's protocol ID
- 403-19
- Status last verified
- Dec 2019
- First submitted
- 28 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function Using Novel Techniques
- ClinicalTrials.gov ID
- NCT04214769
- Acronym / sponsor ID
- 403-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer patients | – | Diagnostic Test: Audiometry and tympanometry, vHIT, VEMP, ENG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed Head and Neck cancers, not treated previously, and planned for radiation therapy in which the inner ear will be radiated
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiometry and tympanometry, vHIT, VEMP, ENGDiagnostic tests | Diagnostic test | Head and Neck Cancer patients |
Primary outcome
Audiometry
Time frame: 1.5 Year
The change in hearing threshold and in the speech-audiometry
ENG test
Time frame: 1.5 Year
Abnormal function of the central vestibular pathways, unilateral weakness of the vestibular apparatus or direction preponderance
VEMP test
Time frame: 1.5 Year
Abnormal latencies, amplitudes, thresholds
vHIT test
Time frame: 1.5 Year
abnormal gain, the appearance of overt and covert saccades
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer Patients Treated With Radiotherapy, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahav Oron, MD (973236973573, oron.yahav@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audiometry (time frame: 1.5 Year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.