Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes: An Exploratory Study
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
- Determine changes in peripheral nerve function in older patients with diabetes and
metastatic solid tumors treated with taxane or platinum-containing chemotherapy
regimens.
- Determine the extent to which age, pre-existing diabetes mellitus, and level of
glycemic control predict a differential pattern in outcome beyond the effect of the
drugs in patients treated with these regimens.
- Develop a clinical assessment that would predict whether or not patients with diabetes
mellitus are more or less susceptible to the neurotoxic effects of chemotherapy.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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