Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

NCT01208545 | Unknown

• 1 other identifier: 99000287
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy; Nerve Degeneration; Nerve Conduction

Keywords

taxol; vincristine; oxaliplatin; chemotherapy; nerve degeneration; nerve conduction; cancer; nerve conduction studies

Outcome Measures

Primary Outcomes (1)

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

  one year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroMetrix, Inc.: lead

Study Sites (1)

Santa Clara Valley Health and Hospital System

Santa Clara, California, 95128, United States

Location

MeSH Terms

Conditions

Nerve Degeneration; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eugene A Lesser, D.O.

  NeuroMetrix, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: September 24, 2010
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Last Updated: September 24, 2010

Record last verified: 2010-09

Locations

US (1)