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Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by NeuroMetrix, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NeuroMetrix, Inc.
ClinicalTrials.gov Identifier:
NCT01208545
First received: September 22, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 22, 2010
September 22, 2010
July 2008
July 2010   (final data collection date for primary outcome measure)
Time in weeks to fifty percent decrease in sural nerve action potential amplitude [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs
Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients presenting to an oncology clinic for treatment of breast cancer, colon cancer, or non-Hodgkins lymphoma, or treatment of advanced gastroesophageal cancer
  • Chemotherapy
  • Nerve Degeneration
  • Nerve Conduction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01208545
99000287
No
Eugene A. Lesser, D.O., Senior Medical Director, NeuroMetrix, Inc.
NeuroMetrix, Inc.
Not Provided
Principal Investigator: Eugene A Lesser, D.O. NeuroMetrix, Inc.
NeuroMetrix, Inc.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP