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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE3Y05 | Other Identifier | Case Comprehensive Cancer Center | |
| 10-05-19 | Other Identifier | University Hospitals IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| management of therapy complications | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing loss as measured by Hearing Loss Inventory, Dizziness Handicap Inventory, and audiogram every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment | every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment | |
| Peripheral neuropathy as measured by Peripheral Neuropathy Scale every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment | every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment |
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DISEASE CHARACTERISTICS:
Diagnosis of solid tumor
No known CNS metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Sabarish Ayyappan, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |