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| Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00305799 |
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.
| Condition | Intervention |
|
Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific |
Procedure: management of therapy complications |
| Genetics Home Reference related topics: | nonsyndromic deafness |
| MedlinePlus related topics: | Cancer Dizziness and Vertigo Hearing Disorders and Deafness Peripheral Nerve Disorders |
| ChemIDplus related topics: | Oxaliplatin |
| 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.
Eligibility
| 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:
Contacts and Locations| 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 | |||||
| Case Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Panos Savvides, MD | Case Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| Study ID Numbers: | CDR0000465215, CASE-3Y05, CASE-100519 |
| First Received: | March 21, 2006 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00305799 |
| Health Authority: | Unspecified |
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