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

Head and Neck Cancer Patients Treated With Radiotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04214769
• Other study ID #: 403-19
• Status: Not yet recruiting
• Start date: March 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2019
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Yahav Oron, MD
• Phone: 973236973573
• Email: oron.yahav[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. To correlate the mean total radiation dose to the cochlea with the effects on audiological and vestibular function

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer Patients Treated With Radiotherapy
• Head and Neck Neoplasms

Intervention

Diagnostic Test:
• Audiometry and tympanometry, vHIT, VEMP, ENG
Diagnostic tests

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

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