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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04092764

Collaborator

(none)

Enrollment

Location

Arm

33.3

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Participants with Sensory NeuropathyParticipants 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 :

Jan 23, 2020

Actual Primary Completion Date :

Nov 9, 2021

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Accessing Level of Peripheral Neuropathy [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

Quality of life Improvement measured with FACT/GOG-NTX Questionnaire [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
1. Nerve compression (carpal tunnel syndrome, sciatica, etc)
1. Previously known leptomeningeal carcinomatosis
1. Evidence of disease in the brain or spine by prior imaging
Comorbidities with documented pre-existing neuropathy prior to the chemotherapy such as
1. Diabetes (HbA1c 6.5% or greater)
1. HIV
1. Multiple myeloma
1. 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.