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NCT Number: NCT04917796

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

This study is a randomized controlled trial of electroacupuncture (referred to as EA) versus sham acupuncture (referred to as EA) as effective treatments for Chemotherapy-Induced Peripheral Neuropathy (CIPN) pain in cancer survivors.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy Agnosia CIPN - Chemotherapy-Induced Peripheral Neuropathy Nerve Pain Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Neuropathy Neuropathy, Painful Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

During the study, patients will be randomized to one of the two possible acupuncture treatment groups and receive 10 treatments over the course of 8 weeks and then enter a follow-up period. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 paresthesia
  • 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

Treatment and study plan

electroacupuncture

Other

Real and sham acupuncture will be delivered by experienced licensed acupuncturists. 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).

Other names: EA

Sham Acupuncture

Other

Real and sham acupuncture will be delivered by experienced licensed acupuncturists. 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).

Primary outcomes

  1. Difference of pain severity from baseline to 4 weeks after baseline.

    Time frame: 4 weeks

    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)

  2. Difference of pain severity from baseline to 8 weeks after baseline.

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center

Registry information

Official study title

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

Acronym: ACT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2021
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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