Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

• Conditions: Chemotherapy; Nerve Degeneration; Nerve Conduction

• Registration Number: NCT01208545
• Lead Sponsor: NeuroMetrix, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2010-07
• Status Verified: 2010-09
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Last Update Submitted: 2010-09-22
• Study First Posted: 2010-09-24
• Last Update Posted: 2010-09-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in weeks to fifty percent decrease in sural nerve action potential amplitude	one year

Trial Locations

Locations (1)

Santa Clara Valley Health and Hospital System; 🇺🇸 Santa Clara, California, United States