What side effects are associated with this type of intervention?

Acupuncture, used for treating peripheral neuropathy, is generally considered safe with minimal side effects, which may include minor bruising, soreness, or bleeding at needle insertion sites. Other common treatments for peripheral neuropathy, such as gabapentin and tricyclic antidepressants, can cause dizziness, sedation, and gastrointestinal issues. Physical modalities like TENS and scrambler therapy are usually well-tolerated but may cause skin irritation or discomfort at the site of application. Complementary therapies like yoga and relaxation therapy have minimal side effects, primarily related to physical strain or discomfort during practice.

What prior FDA approvals exist?

FDA-approved treatments for peripheral neuropathy often include medications that modulate neural pathways to alleviate pain. These include gabapentin and tricyclic antidepressants, which are generally considered effective for reducing neuropathic pain. Additionally, drugs like pregabalin have been used for chemotherapy-induced peripheral neuropathy, showing some promise in clinical trials. While acupuncture itself is not an FDA-approved treatment, its mechanism of modulating pain through neural and biochemical pathways is somewhat mirrored in these pharmacologic treatments.

What other types of research exist?

Promising novel alternatives to acupuncture for peripheral neuropathy patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown significant pain reduction in migraine patients and may be applicable to neuropathy. 2) Remote electrical neuromodulation, which uses nonpainful electrical skin stimulation controlled by a smartphone and has demonstrated efficacy in reducing acute migraine pain. 3) Spinal cord stimulation, which has been effective in managing chronic pain and neuropathy symptoms. 4) Gene therapy, specifically VM202, a plasmid DNA encoding human hepatocyte growth factor, which has shown pain-relieving effects in diabetic peripheral neuropathy. These alternatives offer innovative approaches to pain management through neural and biochemical pathways.

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Acupuncture for Peripheral Neuropathy

N/A

Waitlist Available

Led By Ting Bao, MD, DABMA, MS

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

Solid tumor survivors with no evidence of disease

Moderate to severe CIPN, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating scale (NRS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Summary

This trial is testing whether real acupuncture can help reduce pain and improve symptoms for patients who have nerve damage from chemotherapy. Acupuncture has been studied for its potential benefits in reducing symptoms of nerve damage caused by chemotherapy, with some trials suggesting modest improvements.

Who is the study for?

This trial is for adults over 18 who have survived solid tumors with no current disease and suffer from moderate to severe nerve damage symptoms after chemotherapy. Participants should not have had any changes in their anti-neuropathy medication for three months and must speak English. Those with pacemakers or recent acupuncture treatments are excluded.

What is being tested?

The study aims to assess the effectiveness of real acupuncture versus placebo (sham) acupuncture or usual care in managing symptoms like numbness, tingling, or pain caused by nerve damage from chemotherapy.

What are the potential side effects?

Acupuncture may cause minor side effects such as bruising, bleeding at the needle sites, dizziness, fainting, or worsening of symptoms. The sham procedure might also lead to similar discomforts due to needle insertion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had cancer, but currently show no signs of the disease.

Select...

I experience significant numbness, tingling, or pain in my hands or feet.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in the proportion of patients with a CIPN severity

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Acupuncture Treatment GroupExperimental Treatment2 Interventions

Ten acupuncture treatments over the course of eight weeks, with twice weekly acupuncture treatments for the first two weeks, and then weekly treatment thereafter.

Group II: Usual Care GroupActive Control2 Interventions

Twelve weeks of usual care.

Group III: Sham Acupuncture Treatment GroupPlacebo Group2 Interventions

Ten sham acupuncture treatments over the course of eight weeks, with twice weekly sham acupuncture treatments for the first two weeks, and then weekly sham acupuncture treatment thereafter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acupuncture

2011

Completed Phase 3

~1240

questionnaires

2008

Completed Phase 2

~4390

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for peripheral neuropathy include medications like gabapentin and pregabalin, which work by modulating calcium channels to reduce nerve excitability and pain. Acupuncture, another treatment, stimulates specific points on the body to modulate pain and symptoms through neural, hormonal, and biochemical pathways, potentially altering brain activity and local tissue responses. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, ensuring they choose therapies that best address their symptoms and improve their quality of life.