Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN)

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    12
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 4 March 2021
taxane
paresthesia
numbness
peripheral neuropathy
motor symptoms

Summary

The purpose of the study is to determine the validity of a point-of-care nerve conduction device (NeuroMetrix) and Rydel-Seiffer tuning fork in assessing the level of peripheral neuropathy in patients with chemotherapy-induced peripheral neuropathy (CIPN). Chemotherapy-induced peripheral neuropathy (CIPN) is a common, persistent toxicity among patients who receive chemotherapy. It is characterized by a variety of sensory and motor symptoms such as numbness, tingling, reduced sense of touch, reduced proprioception (awareness of your limb and body position in space), pain, weakness, balance disturbances, and deficits in motor skills.

Details
Condition Chemotherapy Induced Peripheral Neuropathy
Treatment Electroacupuncture, NeuroMetrix, Rydel-Seiffer tuning fork
Clinical Study IdentifierNCT04092764
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on4 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Chemotherapy Induced Peripheral Neuropathy??
Must have undergone chemotherapy with taxane and/or platinum agent
Presence of numbness, paresthesias, loss of deep tendon reflexes, or other symptoms in the lower extremities those were absent prior to treatment with neurotoxic chemotherapy
Three or more months status post platinum containing chemotherapy completion
Grade 1 Level of CIPN that is determined by the NCI Common Toxicity Criteria for Adverse Events

Exclusion Criteria

Peripheral neuropathy from causes other than chemotherapy, such as documented
a. Nerve compression (carpal tunnel syndrome, sciatica, etc)
b. Previously known leptomeningeal carcinomatosis
c. Evidence of disease in the brain or spine by prior imaging
Comorbidities with documented pre-existing neuropathy prior to the chemotherapy such as
a. Diabetes (HbA1c 6.5% or greater)
b. HIV
c. Multiple myeloma
d. Alcoholism
Pain medication dosing, including opioids, anti-convulsants, and anti- depressantshas been increased due to worsening symptoms less than in the two weeks prior to study registration
Current use of acupuncture (manual or electro acupuncture)
Pregnancy
Cardiac issues (AHA class 3 or greater)
Pacemaker or an imbedded neural stimulator
Full therapeutic anticoagulation or a INR > 1.4
Currently undergoing chemotherapy with a platinum agent or have received a platinum chemotherapy agent in the past 3 months
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