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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: | NCT00263861 |
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.
Condition | Intervention |
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Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific |
Procedure: management of therapy complications |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes: An Exploratory Study |
Estimated Enrollment: | 50 |
Study Start Date: | March 2005 |
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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of solid tumor
Planning neoadjuvant or adjuvant treatment of locoregional definitive or systemic therapy comprising ≥ 1 of the following:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5047 |
Principal Investigator: | Constance Visovsky, PhD, RN, ACNP | University of Nebraska |
Study ID Numbers: | CDR0000448645, CASE-CWRU-6Z03 |
Study First Received: | December 7, 2005 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00263861 History of Changes |
Health Authority: | United States: Federal Government |
neurotoxicity unspecified adult solid tumor, protocol specific |
Neurotoxicity Syndromes Poisoning Diabetes Mellitus Disorders of Environmental Origin Taxane |
Neurotoxicity Syndromes Nervous System Diseases Poisoning Disorders of Environmental Origin |