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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04917796
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dana-Farber Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ting Bao, MD
Principal Investigator Affiliation Dana-Farber Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chemotherapy-induced Peripheral Neuropathy, Nerve Pain, Neuropathy, Neuropathy, Painful, Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Electroacupuncture Arm

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.

Placebo Comparator: Sham Acupuncture Arm

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.

Interventions

Other: - 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).

Other: - 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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Ting Bao, MD

[email protected]

857-215-2844

Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

Basking Ridge, New Jersey, 07920

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Middletown, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Montvale, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Memorial Sloan - Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

Rockville Centre, New York

Status

Recruiting

Address

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553

Site Contact

Jun Mao, MD, MSCE

[email protected]

646-888-0863

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