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Electroacupuncture for Neuropathic Pain

Phase 3
Recruiting
Led By Jun Mao, MD, MSCE
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Free of oncologic disease by clinical examination and history
Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Pivotal Trial

Study Summary

This trial will test whether electroacupuncture can help relieve chemotherapy-induced peripheral neuropathy pain.

Who is the study for?
This trial is for English-speaking adults over 18 who have completed certain chemotherapy treatments at least three months ago and are experiencing nerve pain from it. They must not start any new pain medications during the first 12 weeks of the study and should be free of cancer as confirmed by exams and history.Check my eligibility
What is being tested?
The study is testing whether electroacupuncture (EA), which combines acupuncture with electrical stimulation, can reduce nerve pain caused by chemotherapy. Participants will be randomly assigned to receive either EA or sham acupuncture, which does not involve electrical stimulation.See study design
What are the potential side effects?
Acupuncture may cause minor side effects like bruising, bleeding at needle sites, dizziness or fainting. Electroacupuncture might also cause additional discomfort due to the electric current used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have no signs of cancer based on recent exams and my health history.
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I experience mild or greater pain.
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I have moderate to severe nerve pain from chemotherapy, scoring 4 or more on a pain scale.
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I have moderate to severe nerve pain from chemotherapy, scoring 4 or more on a pain scale.
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I experience mild or greater pain.
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I have moderate to severe nerve pain from chemotherapy, scoring 4 or more on a pain scale.
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I finished chemotherapy that can affect nerves 3 months ago.
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I agree not to start any new pain medications for the first 12 weeks of the study.
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I am 18 or older and speak English well.
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I have no signs of cancer based on recent exams and my health history.
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My pain or neuropathy medication has been the same for the last three months.
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I agree not to start any new pain medications for the first 12 weeks of the study.
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I have been diagnosed with CIPN due to symptoms like pain, numbness, or tingling in a pattern that fits like gloves or socks.
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I am willing to follow all study procedures and accept any of the acupuncture treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference of pain severity from baseline to 4 weeks after baseline.
Difference of pain severity from baseline to 8 weeks after baseline.

Side effects data

From 2007 Phase 2 trial • 57 Patients • NCT00071110
32%
INCREASED DREAM ACTIVITY
29%
HEADACHE
25%
REDUCED DURATION OF SLEEP:
25%
NAUSEA / VOMITING
25%
ORGASMIC DYSFUNCTION
11%
DIMINISHED SEXUAL DESIRE
11%
INCREASED DURATION OF SLEEP:
11%
INCREASED TENDENCY TO SWEATING
11%
ORTHOSTATIC DIZZINESS
7%
PHOTOSENSITIVITY
7%
EMOTIONAL INDIFFERENCE
7%
PALPITATIONS / TACHYCARDIA
4%
TENSION / INNER UNREST
4%
FAILING MEMORY
4%
DRY VAGINA
4%
ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY
4%
SLEEPINESS / SEDATION
4%
RASH
4%
DIARRHEA
4%
PRURITUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Electroacupuncture (EA)
Sham Acupuncture (SA)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Electroacupuncture ArmExperimental Treatment1 Intervention
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.
Group II: Sham Acupuncture ArmPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electroacupuncture
2012
Completed Phase 3
~1800

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,920 Previous Clinical Trials
590,353 Total Patients Enrolled
3 Trials studying Peripheral Neuropathy
154 Patients Enrolled for Peripheral Neuropathy
Jun Mao, MD, MSCEPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
1,724 Total Patients Enrolled
Ting Bao, MD, DABMA, MSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
371 Total Patients Enrolled
2 Trials studying Peripheral Neuropathy
103 Patients Enrolled for Peripheral Neuropathy

Media Library

Acupuncture Clinical Trial Eligibility Overview. Trial Name: NCT04917796 — Phase 3
Peripheral Neuropathy Research Study Groups: Sham Acupuncture Arm, Electroacupuncture Arm
Peripheral Neuropathy Clinical Trial 2023: Acupuncture Highlights & Side Effects. Trial Name: NCT04917796 — Phase 3
Acupuncture 2023 Treatment Timeline for Medical Study. Trial Name: NCT04917796 — Phase 3
Peripheral Neuropathy Patient Testimony for trial: Trial Name: NCT04917796 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are actively enrolled in this clinical trial at present?

"Yes, active recruitment is underway for this clinical trial according to the information available on clinicaltrials.gov. The listing for this study was first posted on 5/21/2021 and most recently edited on 4/13/2022. This research project needs to enroll 250 patients at 5 different locations."

Answered by AI

Are patients currently being registered for this clinical trial?

"Yes, this study is still open and recruiting patients. The listing on clinicaltrials.gov notes that the first posting was on May 21st, 2021 and the most recent edit was done on April 13th, 2022."

Answered by AI

How many staff members are managing this research at different sites?

"According to the information available, there are five sites participating in this clinical trial. They are Memorial Sloan Kettering Nassau (Limited protocol activities) in Rockville Centre, Memorial Sloan - Kettering Cancer Center in New york, and Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale. There are also two other locations not mentioned."

Answered by AI

Are there any legal barriers to using electroacupuncture?

"Given that this is a Phase 3 trial with evidence of efficacy as well as multiple rounds of data affirming safety, our team has rated the safety of electroacupuncture at a 3."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
65+
What site did they apply to?
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Memorial Sloan - Kettering Cancer Center
Memorial Sloan Kettering Nassau (Limited protocol activities)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

I have chemo induced neuropathy in my legs and feet. I have tried Gabapentin and found that it really does not work for me. The neuropathy is causing walking difficulties for me.
PatientReceived 2+ prior treatments
~73 spots leftby May 2025