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

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ClinicalTrials.gov Identifier: NCT04092764
Recruitment Status : Active, not recruiting
First Posted : September 17, 2019
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Device: Electroacupuncture Device: NeuroMetrix Device: Rydel-Seiffer tuning fork Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants with Sensory Neuropathy
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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- 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092764


Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Hye Sook Chon, MD Moffitt Cancer Center
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04092764    
Other Study ID Numbers: MCC-20022
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Numbness
Pain
Tingling
Reduced sense of touch
Reduced proprioception
Sensory Neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases