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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE-CWRU-6Z03 | Other Identifier | Case Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may help patients live more comfortably.
PURPOSE: This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors.
OBJECTIVES:
Primary
OUTLINE: This is a longitudinal study.
Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control. Patients are evaluated at baseline, every 3 weeks during chemotherapy for up to 4 treatments, and at 2 months after completion of treatment.
PROJECTED ACCRUAL: A total of 50 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 undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control. |
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous sensation as measured by Semmes-Weinstein monofilaments | baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment | |
| Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument | baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment | |
| Vibration as measured by tuning fork | baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment | |
| Lower extremity muscle strength as measured by Dynamometer | baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment | |
| Blood pressure changes | baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment | |
| Glycemic control as measured by Glycosylated Hemoglobin Assay | baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment |
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DISEASE CHARACTERISTICS:
Diagnosis of solid tumor
Planning neoadjuvant or adjuvant treatment of locoregional definitive or systemic therapy comprising ≥ 1 of the following:
Diagnosis of type I or II diabetes mellitus
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Constance Visovsky, PhD, RN, ACNP | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5047 | 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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