Chemotherapy, Nerve Conduction, Nerve Degeneration
Conditions
Keywords
taxol, vincristine, oxaliplatin, chemotherapy, nerve degeneration, nerve conduction, cancer, nerve conduction studies
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 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.
Interventions
None listed
Sponsors
NeuroMetrix, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in weeks to fifty percent decrease in sural nerve action potential amplitude | one year |
Countries
United States
Outcome results
None listed