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

NCT ID: NCT04092764

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2021-11-11

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Participants Receiving Electroacupuncture

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

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: DEVICE

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.

NeuroMetrix

Intervention Type: DEVICE

The NeuroMetrix is a point-of-care conduction device that will be used to measure peripheral neuropathy

Rydel-Seiffer tuning fork

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

NeuroMetrix

The NeuroMetrix is a point-of-care conduction device that will be used to measure peripheral neuropathy

Intervention Type: 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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hye Sook Chon, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

MCC-20022

Identifier Type: -

Identifier Source: org_study_id