Clinical trial NCT02505672: Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma
Official title: Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: Vestibular function
chemoradiotherapy
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy-proven nasopharyngeal carcinoma who are planned to undergo chemoradiotherapy.

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.


Eligibility 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.

Primary outcomes:
measure: Subjective dizziness and vestibular dysfunction using the dizziness handicap index
timeFrame: 6 months after completion of treatment
measure: Hearing level using standard audiometry
timeFrame: 6 months after completion of treatment
measure: Objective vestibular function using posturography
timeFrame: 6 months after completion of treatment
measure: Vestibular saccular function using vestibular-evoked myogenic potentials
timeFrame: 6 months after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Department of Otolaryngology, Rabin Medical Center
Study officials:
References:
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