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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
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
Free of oncologic disease by clinical examination and history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

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 moderate to severe nerve pain from chemotherapy, scoring 4 or more on a pain scale.
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I have no signs of cancer based on recent exams and my health history.
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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 experience mild or greater pain.
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I finished chemotherapy that can affect nerves 3 months ago.

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%
DRY VAGINA
4%
ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY
4%
RASH
4%
SLEEPINESS / SEDATION
4%
FAILING MEMORY
4%
TENSION / INNER UNREST
4%
DIARRHEA
4%
PRURITUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Electroacupuncture (EA)
Sham Acupuncture (SA)

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
1,944 Previous Clinical Trials
589,501 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
1,820 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: Electroacupuncture Arm, Sham Acupuncture 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
~47 spots leftby May 2025
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