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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04917796
• Other study ID #: 20-426
• Status: Recruiting
• Phase: Phase 3
• Start date: May 21, 2021
• Est. completion date: May 21, 2025

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jun Mao, MD, MSCE
• Phone: 646-888-0863
• Email: maoj[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Electroacupuncture (referred to as EA) may be an effective treatment for Chemotherapy-Induced Peripheral Neuropathy/CIPN pain. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 21, 2025
• Est. primary completion date: May 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 paresthesia73
• 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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Nerve Pain
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Device:
• Electroacupuncture
Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. 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).
• Sham Acupuncture
Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. 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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited protocol activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan - Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited protocol activities)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of pain severity from baseline to 4 weeks after baseline.	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)	4 weeks
Primary	Difference of pain severity from baseline to 8 weeks after baseline.	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	8 weeks

External Links

•   Memorial Sloan Kettering Cancer Center