RECRUITING

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

Conditions

Chemotherapy-induced Peripheral Neuropathy Nerve Pain Neuropathy Neuropathy, Painful CIPN Electroacupuncture Cancer survivor Acupuncture Memorial Sloan Kettering Cancer Center Dana-Farber Cancer Institute

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-21

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04917796

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* Patients with a pacemaker or other electronically charged medical device * Use of acupuncture for symptom management within the past 12 months

Inclusion Criteria

Exclusion 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

* Patients with a pacemaker or other electronically charged medical device
* Use of acupuncture for symptom management within the past 12 months

Contacts and Locations

Study Contact

Ting Bao, MD

CONTACT

857-215-2844

ting_bao@dfci.harvard.edu

Anna Tanasijevic, MPH

CONTACT

617-632-5584

anna_tanasijevic@dfci.harvard.edu

Principal Investigator

Ting Bao, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021

United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Ting Bao, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-21

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-05-21

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Chemotherapy-induced Peripheral Neuropathy
CIPN
Electroacupuncture
Nerve pain
Cancer survivor
Acupuncture
Memorial Sloan Kettering Cancer Center
Neuropathy
Dana-Farber Cancer Institute

Additional Relevant MeSH Terms

Chemotherapy-induced Peripheral Neuropathy
Nerve Pain
Neuropathy
Neuropathy, Painful