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Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by NeuroMetrix, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208545
First Posted: September 24, 2010
Last Update Posted: September 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NeuroMetrix, Inc.
  Purpose
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.

Condition
Chemotherapy Nerve Degeneration Nerve Conduction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

Further study details as provided by NeuroMetrix, Inc.:

Primary Outcome Measures:
  • Time in weeks to fifty percent decrease in sural nerve action potential amplitude [ Time Frame: one year ]

Estimated Enrollment: 120
Study Start Date: July 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to an oncology clinic for treatment of breast cancer, colon cancer, or non-Hodgkins lymphoma, or treatment of advanced gastroesophageal cancer
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208545


Locations
United States, California
Santa Clara Valley Health and Hospital System
Santa Clara, California, United States, 95128
Sponsors and Collaborators
NeuroMetrix, Inc.
Investigators
Principal Investigator: Eugene A Lesser, D.O. NeuroMetrix, Inc.
  More Information

Responsible Party: Eugene A. Lesser, D.O., Senior Medical Director, NeuroMetrix, Inc.
ClinicalTrials.gov Identifier: NCT01208545     History of Changes
Other Study ID Numbers: 99000287
First Submitted: September 22, 2010
First Posted: September 24, 2010
Last Update Posted: September 24, 2010
Last Verified: September 2010

Keywords provided by NeuroMetrix, Inc.:
taxol
vincristine
oxaliplatin
chemotherapy
nerve degeneration
nerve conduction
cancer
nerve conduction studies

Additional relevant MeSH terms:
Nerve Degeneration
Pathologic Processes