At a glance
ClinicalIndex Comparison Record- ✓Scheduled to receive chemotherapy with taxane compounds for breast cancer treatment
- ✓No prior taxane or platinum chemotherapy
- ✓Life expectancy ≥12 months
- ✓Age ≥18 years
- ✕Central nervous system or other impairments that interfere with clinical and electrophysiological assessment
- ✕Pacemaker or other metallic objects contraindicated for MRI
- ✕Requirement for supplemental oxygen at baseline or severe COPD
- ✕Previous exposure to neurotoxic chemotherapeutic agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity: Better Tools and Understanding
In Brief
A clinical study evaluating EPR Oximetry for CIPN - Chemotherapy-Induced Peripheral Neuropathy. Completed, enrolled 7 participants across 1 site.
Detailed Summary
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).
Study Details
Timeline
Interventions
Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.