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Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs


N/A
18 Years
80 Years
Open (Enrolling)
Both
Chemotherapy, Nerve Degeneration, Nerve Conduction

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Trial Information

Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time in weeks to fifty percent decrease in sural nerve action potential amplitude

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Eugene A Lesser, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NeuroMetrix, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

99000287

NCT ID:

NCT01208545

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Chemotherapy
  • Nerve Degeneration
  • Nerve Conduction
  • taxol
  • vincristine
  • oxaliplatin
  • chemotherapy
  • nerve degeneration
  • nerve conduction
  • cancer
  • nerve conduction studies
  • Nerve Degeneration

Name

Location

Santa Clara Valley Health and Hospital SystemSanta Clara, California  95128