Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma

April 16, 2016 updated by: yotam shkedy, Rabin Medical Center

Nasopharyngeal carcinoma (NPC) is usually treated with chemoradiotherapy. While the effects of this treatment on cochlear function is well characterized, its effect on vestibular function is not well studied.

In this study the investigators will study the vestibular function of 50 patients undergoing chemoradiotherapy for NPC both before and after treatment in order to better define its effects. All patients will undergo a validated questionnaire (dizziness handicap index), posturography, audiometry and vestibular-evoked myogenic potentials.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Petach Tikva, Israel
        • Department of Otolaryngology, Rabin Medical Center
        • Contact:
        • Principal Investigator:
          • Yotam Shkedy, MD
        • Sub-Investigator:
          • Aaron Popovtzer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with biopsy-proven nasopharyngeal carcinoma who are planned to undergo chemoradiotherapy.

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Biopsy-proven NPC.
  • About to undergo chemoradiotherapy with intensity-modulated radiotherapy (IMRT).

Exclusion Criteria:

  • Pregnancy.
  • Prior vestibular dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Patients older than 18 who are planned to undergo chemoradiotherapy for nasopharyngeal carcinoma.
Radiation: Chemoradiotherapy for nasopharyngeal carcinoma
Note that this is standard care for NPC and patients are not assigned to different intervention groups. All patients in the study will receive the same treatment (chemoradiotherapy) and will be observed for changes in vestibular function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective dizziness and vestibular dysfunction using the dizziness handicap index
Time Frame: 6 months after completion of treatment
6 months after completion of treatment
Hearing level using standard audiometry
Time Frame: 6 months after completion of treatment
6 months after completion of treatment
Objective vestibular function using posturography
Time Frame: 6 months after completion of treatment
6 months after completion of treatment
Vestibular saccular function using vestibular-evoked myogenic potentials
Time Frame: 6 months after completion of treatment
6 months after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 18, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 16, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0361-14-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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