The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment

Acupuncture for Taxane-Induced Peripheral Neuropathy Prevention (ATP): A Phase II Randomized, Placebo Controlled Trial

Some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (TIPN). TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. The purpose of this study is to learn if acupuncture can prevent TIPN from getting worse. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. We will compare real acupuncture (RA) to placebo (sham) acupuncture (SA). SA is done like RA, but will use different needles and target different sites or places on the body than RA. We are comparing RA to SA to learn whether RA can prevent TIPN from getting worse while receiving taxane.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Taxane-Induced Peripheral Neuropathy
• Intervention / Treatment: Procedure: Real Acupuncture; Other: Sham Acupuncture

Detailed Description

The study will include two phases. The first phase is the screening phase, in which patients with early stage breast cancer undergoing taxane therapy will consent and receive TIPN screening each week till they develop grade 1 or higher by CTCAE criteria. The patients with TIPN grade 1 or higher will then be consented to the intervention phase, in which patients will be randomized to receive either weekly real or sham acupuncture treatment using a standardized, semi-fixed protocol developed in our preliminary studies to improve TIPN pain. The participant may also participate in Part 2 of the study if they begin to experience TIPN but do not participate in Part 1.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Suffolk- Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rockville Centre, New York, United States, 11553
      • Memorial Sloan Kettering Nassau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Screening Phase:

• English or Spanish-proficient men and women aged ≥18 years
• Histological diagnoses of invasive carcinoma of the breast
• Plan to receive curative intent chemotherapy regimen containing 12 weeks weekly paclitaxel or nab-paclitaxel as standard of care

Intervention Phase:

• TIPN grade ≥1 based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, developed while receiving taxane
• ≥ 4 4 weeks of either weekly paclitaxel or nab-paclitaxel, or paclitaxel or abraxane with dosing every 2-3 weeks planned, as standard of care and at treating physician's discretion
• Willing to adhere to requirement that no new pain medication or dose changes 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:

Screening Phase:

• Pre-existing peripheral neuropathy within 28 days of screening consent
• Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine

Intervention Phase:

• Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
• Use of acupuncture for symptom management within 28 days of intervention consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: real acupuncture (RA); Real Acupuncture weekly till taxane completion	Procedure: Real Acupuncture; Real Acupuncture weekly till taxane completion
Placebo Comparator: sham acupuncture (SA); Sham Acupuncture weekly till taxane completion	Other: Sham Acupuncture; Sham Acupuncture weekly till taxane completion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic Pain Scale (NPS)	Evaluate the effectiveness of real acupuncture versus sham acupuncture in preventing TIPN progression as measured by the Neuropathic Pain Scale (NPS) in patients with early stage breast cancer who are receiving curative intent weekly taxane containing regimen and who have grade ≥ 1 TIPN	at 4 weeks

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Gateway for Cancer Research
• Investigators: Principal Investigator: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Acupuncture; Peripheral Neuropathy; 22-197
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: 22-197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No