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Electroacupuncture for Neuropathic Pain

N/A

Recruiting

Led By Ting Bao, MD

Research Sponsored by Dana-Farber Cancer Institute

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

Summary

This trial is testing if electroacupuncture, which uses needles and a small electrical current, can help reduce pain in cancer survivors who have pain from chemotherapy. Electroacupuncture has been studied for its potential to relieve cancer pain and improve quality of life in cancer patients.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

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

Primary study objectives

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%

ORTHOSTATIC DIZZINESS

11%

INCREASED DURATION OF SLEEP:

11%

INCREASED TENDENCY TO SWEATING

11%

DIMINISHED SEXUAL DESIRE

PALPITATIONS / TACHYCARDIA

EMOTIONAL INDIFFERENCE

PHOTOSENSITIVITY

ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY

SLEEPINESS / SEDATION

FAILING MEMORY

TENSION / INNER UNREST

DIARRHEA

RASH

PRURITUS

DRY VAGINA

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met