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

NCT04092764 | Completed DMC

• 1 other identifier: MCC-20022
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Keywords

Numbness; Pain; Tingling; Reduced sense of touch; Reduced proprioception; Sensory Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of life Improvement measured with FACT/GOG-NTX Questionnaire

  Baseline to 30 days after 3 week treatment sessions

• Quality of life Improvement measured the Neuropathic pain scale (NPS)

  Baseline to 30 days after 3 week treatment sessions

Study Arms (1)

Participants Receiving Electroacupuncture

EXPERIMENTAL

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

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

Interventions

Electroacupuncture 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.

Participants Receiving Electroacupuncture

NeuroMetrix DEVICE

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

Participants Receiving Electroacupuncture

Rydel-Seiffer tuning fork 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

Participants Receiving Electroacupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Hypesthesia; Pain; Paresthesia

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Hye Sook Chon, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with Sensory Neuropathy

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: January 23, 2020
• Primary Completion: November 9, 2021
• Study Completion: November 11, 2021
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)