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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Device: Rydel-Seiffer tuning fork; Device: NeuroMetrix; Device: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04092764

MCC-20022

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Participants Receiving Electroacupuncture

Experimental group

Description:

Participants will receive electroacupuncture for 30 minutes once per week for a total of 3 weeks.

Treatment:

Device: NeuroMetrix

Device: Electroacupuncture

Device: Rydel-Seiffer tuning fork