The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)

Study Overview
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Brief Summary
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Electroacupuncture (referred to as EA) may be an effective treatment for Chemotherapy-Induced Peripheral Neuropathy/CIPN pain. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. EA involves adding a very small amount of electricity through the acupuncture needles (electrical stimulation). Researchers have found that EA can increase the effects of regular acupuncture, and it is particularly helpful for treating different kinds of pain. The purpose of this study is to learn if EA can improve CIPN pain in cancer survivors, and if it is effective against other CIPN-related symptoms.

Official Title
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A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)

Conditions
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Chemotherapy-induced Peripheral Neuropathy, Nerve Pain

Intervention / Treatment
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* Device: Electroacupuncture
* Device: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-proficient men and women aged ≥18 years Free of oncologic disease by clinical examination and history Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia73 Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week On a stable regimen (no change in the past three months) if taking anti-neuropathy or other pain medications Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments Exclusion Criteria: Patients with a pacemaker or other electronically charged medical device Use of acupuncture for symptom management within the past 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture Arm<br>The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms. | Device: Electroacupuncture<br>* Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. The intervention includes 10 treatments of acupuncture over 8 weeks (i.e., twice per week for two weeks, then one treatment per week for six weeks).<br>* Other names: EA;|
| Placebo Comparator: Sham Acupuncture Arm<br>The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms. | Device: Sham Acupuncture<br>* Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. The intervention includes 10 treatments of acupuncture over 8 weeks (i.e., twice per week for two weeks, then one treatment per week for six weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of pain severity from baseline to 4 weeks after baseline. | The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form (BPI-SF) | 4 weeks | 
| Difference of pain severity from baseline to 8 weeks after baseline. | The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy-induced Peripheral Neuropathy, CIPN, Electroacupuncture, Nerve pain, Cancer survivor, 20-246, Memorial Sloan Kettering Cancer Center