Status:
UNKNOWN
Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs
Lead Sponsor:
NeuroMetrix, Inc.
Conditions:
Chemotherapy
Nerve Degeneration
Eligibility:
All Genders
18-80 years
Brief Summary
The study hypothesis is that changes in serially obtained nerve conduction study data obtained every 3-4 weeks in cancer patients receiving chemotherapy can be used to predict the development of a cli...
Eligibility Criteria
Inclusion
- Clinical diagnosis of untreated breast cancer, treated (advance stage) or untreated colon cancer, untreated non-Hodgkins lymphoma, or advanced gastroesophageal cancer scheduled to begin chemotherapy with either Taxol, oxaliplatin, or vincristine
Exclusion
- Individuals with an implanted electronic medical devices (cardiac pacemaker or defibrillator, vagus nerve stimulator, deep brain stimulator, intrathecal pump, others)
- Individuals whose chemotherapy regimen will include nerve toxic drugs other than Taxol, oxaliplatin, or vincristine, or includes more than one of these three drugs in combination
- Individuals whose screening nerve conduction studies show peroneal motor amplitude \< 1 mV bilaterally or sural sensory amplitude \< 3 uV bilaterally or no result obtainable
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01208545
Start Date
July 1 2008
Last Update
September 24 2010
Active Locations (1)
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1
Santa Clara Valley Health and Hospital System
Santa Clara, California, United States, 95128