Peripheral Neuropathy Clinical Trial
Official title:
Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer
Purpose: The purpose of the study is to test a new way of measuring nerve damage in women with breast cancer receiving chemotherapy drug paclitaxel (Taxol).
Purpose: The study has four aims;
- The primary aim of the study is to determine whether women who are receiving either
weekly Taxol (80-100 mg/m2) or bi-weekly Taxol (i.e.,dose-dense; 175 mg/m2) show
deficits in axon-reflex mediated vasodilation (AMV) over the course of six weeks of
Taxol therapy similar to those that have been reported in patients with diabetic and
genetically-inherited neuropathies.
- The second aim of the study is to determine whether women who are receiving either
weekly or dose-dense Taxol develop changes in AMV before developing signs & symptoms of
chemotherapy-induced peripheral neuropathy (CIPN) in a way that supports using changes
in AMV as an early detection method for small-fiber CIPN.
- A third (exploratory) aim of the study is to determine whether any changes in AMV
detected during the study are significantly correlated with self-reported CIPN in a way
that would support using changes in AMV as a confirmatory marker for CIPN.
- A final (exploratory) aim of the study is to describe the size of axon reflexes and axon
flares in women receiving weekly Taxol before they start their pre-Taxol anthracycline &
cyclophosphamide (AC) therapy.
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