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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
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.
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cutaneous sensation as measured by Semmes-Weinstein monofilaments
Time frame: 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
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Vibration as measured by tuning fork
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Lower extremity muscle strength as measured by Dynamometer
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Blood pressure changes
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Glycemic control as measured by Glycosylated Hemoglobin Assay
Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.