Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes: An Exploratory Study
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Cutaneous sensation as measured by Semmes-Weinstein monofilaments
baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
No
Constance Visovsky, PhD, RN, ACNP
Principal Investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CWRU6Z03
NCT00263861
March 2005
September 2007
Name | Location |
---|---|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |