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Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors - NCT00305799-44106(Clinical Trial 139011)



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City:  Cleveland
State:  
OH
Zip Code: 44106
Conditions: Neurotoxicity - Unspecified Adult Solid Tumor, Protocol Specific
Purpose: RATIONALE: Understanding how oxaliplatin affects hearing loss, dizziness, and peripheral neuropathy may improve the ability to plan effective treatment for patients receiving oxaliplatin for solid tumors. PURPOSE: This clinical trial is studying hearing loss and dizziness in patients receiving oxaliplatin for solid tumors.
Study summary: OBJECTIVES: - 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.
Criteria: DISEASE CHARACTERISTICS: - Diagnosis of solid tumor - Received an oxaliplatin-containing chemotherapy regimen within the past 15 months* NOTE: *If oxaliplatin was omitted from the patient's most recent chemotherapy regimen due to ototoxicity, the patient is still eligible for participation in this study - No known CNS metastases 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
Study is available at: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, OH 44106
United States

Primary Contact:
Panayiotis Savvides, MD
Email: ssp14@case.edu
Phone: 216-844-5946
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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