Effect of Radiation Therapy Among Head and Neck Cancer Pa... | NCT04214769

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

NCT04214769

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jan 2, 2020Actual

Enrollment

17Estimated

Phase

Not provided

Conditions

Head and Neck Cancer Patients Treated With Radiotherapy

Interventions

Audiometry and tympanometry, vHIT, VEMP, ENG

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Estimated

Primary Completion Date

Aug 31, 2021Estimated

Completion Date

Aug 31, 2021Estimated

First Submitted Date

Dec 28, 2019

First Submission Date that Met QC Criteria

Dec 28, 2019

First Posted Date

Jan 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2019

Last Update Posted Date

Jan 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Head and Neck Cancer patients			Diagnostic Test: Audiometry and tympanometry, vHIT, VEMP, ENG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Audiometry and tympanometry, vHIT, VEMP, ENG	Diagnostic Test	Diagnostic tests	Head and Neck Cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yahav Oron, MD	Contact	973236973573		oron.yahav@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001299	Audiometry
D000158	Acoustic Impedance Tests
D004584	Electronystagmography

Ancestor Terms

ID	Term
D006320	Hearing Tests
D003939	Diagnostic Techniques, Otological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided