Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs
Status unconfirmed
Conditions studied: Chemotherapy, Nerve Degeneration, Nerve Conduction
In brief
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 clinically significant / disabling drug induced neuropathy six and twelve months following the start of treatment. Patients with breast cancer, colon cancer, gastroesophageal cancer, and non-Hodgkins lymphoma will be enrolled. Six lower extremity nerves--three in each leg--will be electrically stimulated and their responses recorded at three to four week intervals coinciding with patient's scheduled chemotherapy.
Key facts
- Study ID
- NCT01208545
- Run by
- NeuroMetrix, Inc.
- People needed
- 120
- Starts
- 2008-07-01
- Last updated by the study team
- 2010-09-24
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Santa Clara Valley Health and Hospital System — Santa Clara, California, United States
Full record on ClinicalTrials.gov
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