Biomarkers In Chemotherapy-Induced Peripheral Neurotoxicity: Better Tools And Understanding
This pilot study will attempt to establish the feasibility of using tissue oxygen
measurements and the protein, neurofilament light chain (NF-L), as potential biomarkers for
chemotherapy-induced peripheral neuropathy (CIPN). Thirty (30) subjects scheduled to begin
taxane-based chemotherapy for breast tumor will be assigned to receive an India ink injection
under the skin of the foot. The ink will be used to make up to five (5) 45-minute "electron
paramagnetic resonance" (EPR) oximetry readings prior to the start of chemotherapy. Subjects
will undergo electrophysiologic assessments including nerve conduction studies, in addition
to a neurological examination prior to the start of chemotherapy. Subjects will have the EPR
oximetry readings, electrophysiologic tests, and neurological examination two more times: at
the halfway point of their chemotherapy treatment -- or at the onset of CIPN symptoms -- and
again after chemotherapy has been completed. Subjects will also have blood drawn prior to
beginning taxane-based chemotherapy, prior to every scheduled chemotherapy treatment, and
after completion of chemotherapy in order to test for neurofilament light chain (NF-L).
View more details from ClinicalTrials.gov.
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