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

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electroacupuncture
NeuroMetrix
Rydel-Seiffer tuning fork
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Numbness, Pain, Tingling, Reduced sense of touch, Reduced proprioception, Sensory Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Moffitt Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants Receiving Electroacupuncture

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 13, 2019
Last Updated
November 2, 2022
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04092764
Brief Title
Feasibility Study for Electroacupuncture for Chemotherapy- Induced Peripheral Neuropathy (CIPN)
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
November 9, 2021 (Actual)
Study Completion Date
November 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy
Keywords
Numbness, Pain, Tingling, Reduced sense of touch, Reduced proprioception, Sensory Neuropathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants with Sensory Neuropathy
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants Receiving Electroacupuncture
Arm Type
Experimental
Arm Description
Participants will receive electroacupuncture for 30 minutes once per week for a total of 3 weeks.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Intervention Description
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
Intervention Name(s)
NeuroMetrix
Intervention Description
The NeuroMetrix is a point-of-care conduction device that will be used to measure peripheral neuropathy
Intervention Type
Device
Intervention Name(s)
Rydel-Seiffer tuning fork
Intervention Description
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
Primary Outcome Measure Information:
Title
Accessing Level of Peripheral Neuropathy
Description
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.
Time Frame
Baseline to 30 days after 3 week treatment sessions
Secondary Outcome Measure Information:
Title
Quality of life Improvement measured with FACT/GOG-NTX Questionnaire
Description
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.
Time Frame
Baseline to 30 days after 3 week treatment sessions
Title
Quality of life Improvement measured the Neuropathic pain scale (NPS)
Description
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.
Time Frame
Baseline to 30 days after 3 week treatment sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hye Sook Chon, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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