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Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02505672
Recruitment Status : Unknown
Verified April 2016 by yotam shkedy, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2015
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
yotam shkedy, Rabin Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment
Nasopharyngeal Carcinoma Radiation: Chemoradiotherapy for nasopharyngeal carcinoma

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma
Study Start Date : August 2016
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Subjective dizziness and vestibular dysfunction using the dizziness handicap index [ Time Frame: 6 months after completion of treatment ]
  2. Hearing level using standard audiometry [ Time Frame: 6 months after completion of treatment ]
  3. Objective vestibular function using posturography [ Time Frame: 6 months after completion of treatment ]
  4. Vestibular saccular function using vestibular-evoked myogenic potentials [ Time Frame: 6 months after completion of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with biopsy-proven nasopharyngeal carcinoma who are planned to undergo chemoradiotherapy.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505672


Contacts
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Contact: Yotam Shkedy, MD +972-3-9376458 yotamyo@clalit.org.il

Locations
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Israel
Department of Otolaryngology, Rabin Medical Center Not yet recruiting
Petach Tikva, Israel
Contact: Yotam Shkedy, MD    +972-3-9376458    yotamyo@clalit.org.il   
Principal Investigator: Yotam Shkedy, MD         
Sub-Investigator: Aaron Popovtzer, MD         
Sponsors and Collaborators
Rabin Medical Center

Publications:

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Responsible Party: yotam shkedy, Resident, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02505672     History of Changes
Other Study ID Numbers: 0361-14-RMC
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by yotam shkedy, Rabin Medical Center:
Vestibular function
chemoradiotherapy

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases