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

Dana-Farber Cancer Institute

Status: Active, not recruiting

Conditions: Nerve Pain; Chemotherapy-induced Peripheral Neuropathy; CIPN - Chemotherapy-Induced Peripheral Neuropathy; Neuropathy, Painful; Neuropathy; Pain

Treatments: Other: Sham Acupuncture; Other: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04917796

23-510

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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255 participants in 2 patient groups, including a placebo group

Electroacupuncture Arm

Experimental group

Description:

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:

Other: Electroacupuncture

Sham Acupuncture Arm

Placebo Comparator group

Description:

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:

Other: Sham Acupuncture