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Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

NCT ID: NCT01208545

Last Updated: 2010-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chemotherapy Nerve Degeneration Nerve Conduction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeuroMetrix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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NeuroMetrix, Inc.

Principal Investigators

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Eugene A Lesser, D.O.

Role: PRINCIPAL_INVESTIGATOR

NeuroMetrix, Inc.

Locations

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Santa Clara Valley Health and Hospital System

Santa Clara, California, United States

Site Status

Countries

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United States

Other Identifiers

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99000287

Identifier Type: -

Identifier Source: org_study_id