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Clinical Trial 20022

Cancer Type: Gynecological Tumor
Study Type: Supportive Care
NCT#: NCT04092764

Phase: N/A
Principal Investigator: Chon, Hye Sook

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or 1-800-679-0775 Learn More
Overview

Study Title

Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN) Using a Point-Of-Nerve Conduction Device (NeuroMetrix) and the Rydel-Seiffer Tuning Fork

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.

Objective

The primary objectives of this single-arm pilot study is to validate the a point-of-care nerve conduction device ( NeuroMetrix) and Rydel-Seiffer tuning fork as a measurement tool of acupuncture in treatment of patients who suffered from chemotherapy-induced peripheral neuropathy (CIPN). We hypothesize that the inter-operator variability between neurologist and non-neurologist providing measurements independently back-to-back the same day without cross-comparing will have no more than 15% variability

Treatments

Therapies

Therapy (NOS)

Medications

Not Applicable ()

Inclusion Criteria

>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- depressants, has been increased due to worsening symptoms less than 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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