Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors
NCT ID: NCT00305799
Last Updated: 2014-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
59 participants
OBSERVATIONAL
2005-11-30
2014-11-30
Brief Summary
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PURPOSE: This clinical trial is studying hearing loss and dizziness in patients receiving oxaliplatin for solid tumors.
Detailed Description
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* Define the prevalence of audiometrically detectable hearing loss in patients with solid tumors treated with oxaliplatin.
* Describe the association of chemotherapy-induced peripheral neuropathy (CIPN) and audiometrically detectable hearing loss in these patients.
* Describe the association of CIPN and patient self-reported scales including, Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory.
OUTLINE: This is an exploratory study.
Patients will complete three self-reported questionnaires including the Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory. Patients will also be asked a series of questions regarding symptoms or complaints about hearing changes, tinnitus, and dizziness that they may have experienced prior to, during, and after completion of chemotherapy. Patients will also undergo a hearing test.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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management of therapy complications
Patients will complete three self-reported questionnaires including the Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory. Patients will also be asked a series of questions regarding symptoms or complaints about hearing changes, tinnitus, and dizziness that they may have experienced prior to, during, and after completion of chemotherapy. Patients will also undergo a hearing test.
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS:
* No history of spinal injuries
* ECOG performance status 0-3
* No history of chronic renal failure
* No known HIV/AIDS
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sabarish Ayyappan, MD
Role: STUDY_CHAIR
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE3Y05
Identifier Type: OTHER
Identifier Source: secondary_id
10-05-19
Identifier Type: OTHER
Identifier Source: secondary_id
CASE3Y05
Identifier Type: -
Identifier Source: org_study_id