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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2020

Interventions

  • Device: Electroacupuncture
    • Participants will receive electroacupuncture for 30 minutes once per week for a total of 3 weeks. The acupoints will be stimulated by the electroacupuncture machine with alternating frequencies in order to induce endorphins at different points in the nervous system. Frequencies between 2 Hz and 100 Hz will be utilized. Sterile single-use needles will be placed at Ba Feng, four points on the dorsum of each foot between the digits. KI2 (Rang Gu), a point located at the soles of the feet and SP-4 (Gongsun) will also be needled per recommendation of our acupuncturist. A total of 12 needles will be used per participant.
  • Device: NeuroMetrix
    • The NeuroMetrix is a point-of-care conduction device that will be used to measure peripheral neuropathy
  • Device: Rydel-Seiffer tuning fork
    • The level of periphal neuropathy will be measured by vibration detection using a Rydel-Seiffer graduated tuning fork placed on the dorsum of the right great toe between the nail and the distal interphalangeal joint. The two arms of the 128 Hz tuning fork are fitted with calibrated weights at the ends, and as the amplitude decreases, the intersection of the triangles moves upward on the weight. This test will be performed three times and a mean of the scores calculated. Vibration sensation is lost sooner in CIPN, which means that lower scores are associated with increased CIPN

Arms, Groups and Cohorts

  • Experimental: Participants Receiving Electroacupuncture
    • Participants will receive electroacupuncture for 30 minutes once per week for a total of 3 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Accessing Level of Peripheral Neuropathy
    • Time Frame: Baseline to 30 days after 3 week treatment sessions
    • Participants with chemotherapy-induced peripheral neuropathy (CIPN) will have their level of periphal neuropathy assessed with the Rydel-Seiffer Tuning Fork while using a point-of-care conduction device (NeuroMetrix). The level of periphal neuropathy will be measured by vibration detection using a Rydel-Seiffer graduated tuning fork placed on the dorsum of the right great toe between the nail and the distal interphalangeal joint. The two arms of the 128 Hz tuning fork are fitted with calibrated weights at the ends, and as the amplitude decreases, the intersection of the triangles moves upward on the weight. This test will be performed three times and a mean of the scores calculated. Vibration sensation is lost sooner in CIPN, which means that lower scores are associated with increased CIPN.

Secondary Measures

  • Quality of life Improvement measured with FACT/GOG-NTX Questionnaire
    • Time Frame: Baseline to 30 days after 3 week treatment sessions
    • Quality of life improvement with electroacupuncture treatment will be measured using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire (FACT/GOG-NTX). The FACT/GOG-NTX questionnaire uses 37 questions with a scale ranging from 0-4, with 0 being Not at All and 4 being Very Much.
  • Quality of life Improvement measured the Neuropathic pain scale (NPS)
    • Time Frame: Baseline to 30 days after 3 week treatment sessions
    • The NPS has 3 questions using a scale ranging from 0-100 with 0 being No Numbess Sensation to 100 being Worst Numbness Imaginable. The NPS also has 10 Yes or No questions about pain. A score of 1 is given to each question answered Yes and a score of 0 to each questions answered No. The total score is calculated as the sum of the 10 questions, and the cut off value for the diagnosis of neuropathic pain is 4/10.

Participating in This Clinical Trial

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, must be stable 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 PT > 1.4
  • Currently undergoing chemotherapy with a platinum agent or have received a platinum chemotherapy agent in the past 3 months.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • H. Lee Moffitt Cancer Center and Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hye Sook Chon, MD, Principal Investigator, Moffitt Cancer Center

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