Overview

This trial is active, not recruiting.

Conditions chemotherapy, nerve degeneration, nerve conduction
Sponsor NeuroMetrix, Inc.
Start date July 2008
End date July 2010
Trial size 120 participants
Trial identifier NCT01208545, 99000287

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Time in weeks to fifty percent decrease in sural nerve action potential amplitude
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs
Principal investigator Eugene A Lesser, D.O.
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by NeuroMetrix, Inc..