Clinical Trial: Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs
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.
Detailed Summary:
Sponsor: NeuroMetrix, Inc.
Current Primary Outcome: Time in weeks to fifty percent decrease in sural nerve action potential amplitude [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: NeuroMetrix, Inc.
Dates:
Date Received: September 22, 2010
Date Started: July 2008
Date Completion:
Last Updated: September 22, 2010
Last Verified: September 2010