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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00305799 |
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.
Condition | Intervention |
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Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific |
Procedure: management of therapy complications |
Study Type: | Observational |
Official Title: | Auditory and Vestibular Function Evaluation in Patients With Solid Tumors Treated With Oxaliplatin-Containing Chemotherapy |
Estimated Enrollment: | 60 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of solid tumor
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 |
Study Chair: | Panos Savvides, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000465215, CASE-3Y05, CASE-100519 |
Study First Received: | March 21, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00305799 History of Changes |
Health Authority: | Unspecified |
neurotoxicity unspecified adult solid tumor, protocol specific |
Oxaliplatin Deafness Neurotoxicity Syndromes Dizziness Hearing Loss |
Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |