Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

Chemotherapy Clinical Trial

Official title:

Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01208545
• Other study ID #: 99000287
• Status: Active, not recruiting
• Phase: N/A
• First received: September 22, 2010
• Last updated: September 22, 2010
• Start date: July 2008

Study information

• Verified date: September 2010
• Source: NeuroMetrix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chemotherapy
• Nerve Conduction
• Nerve Degeneration

Locations

Country	Name	City	State
United States	Santa Clara Valley Health and Hospital System	Santa Clara	California

Sponsors (1)

Lead Sponsor	Collaborator
NeuroMetrix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in weeks to fifty percent decrease in sural nerve action potential amplitude		one year	No