Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

Sponsor

NeuroMetrix, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01208545

Collaborator

(none)

120

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy Nerve Degeneration Nerve Conduction

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

Study Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Jul 1, 2010

Outcome Measures

Primary Outcome Measures

Time in weeks to fifty percent decrease in sural nerve action potential amplitude [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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