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

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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Device: Electroacupuncture; Device: NeuroMetrix; Device: Rydel-Seiffer tuning fork

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accessing Level of Peripheral Neuropathy	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.	Baseline to 30 days after 3 week treatment sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life Improvement measured with FACT/GOG-NTX Questionnaire	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.	Baseline to 30 days after 3 week treatment sessions
Quality of life Improvement measured the Neuropathic pain scale (NPS)	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.	Baseline to 30 days after 3 week treatment sessions

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Hye Sook Chon, MD, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): November 9, 2021
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Numbness; Tingling; Reduced sense of touch; Reduced proprioception; Sensory Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: MCC-20022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes