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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05458284
Recruitment Status : Recruiting
First Posted : July 14, 2022
Last Update Posted : January 11, 2023
Sponsor:
Collaborator:
Gateway for Cancer Research
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Taxane-Induced Peripheral Neuropathy Procedure: Real Acupuncture Other: Sham Acupuncture Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Acupuncture for Taxane-Induced Peripheral Neuropathy Prevention (ATP): A Phase II Randomized, Placebo Controlled Trial
Actual Study Start Date : July 11, 2022
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Neuropathic Pain Scale (NPS) [ Time Frame: at 4 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast Cancer
Accepts Healthy Volunteers:   No
Criteria

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 weeks of weekly paclitaxel or nab-paclitaxe 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05458284


Contacts
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Contact: Ting Bao, MD 646-608-8561 baot@mskcc.org
Contact: Wanqing Zhi, MD, PhD 631-623-4246

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Ting Bao, MD    646-608-8561      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Ting Bao, MD    646-608-8561      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Ting Bao, MD    646-608-8561      
United States, New York
Memorial Sloan Kettering Suffolk- Commack Recruiting
Commack, New York, United States, 11725
Contact: Ting Bao, MD    646-608-8561      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Ting Bao, MD    646-608-8561      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ting Bao, MD    646-608-8561      
Contact: Wanqing Zhi, MD, PhD    631-623-4246      
Memorial Sloan Kettering Nassau Recruiting
Rockville Centre, New York, United States, 11553
Contact: Ting Bao, MD    646-608-8561      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Gateway for Cancer Research
Investigators
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Principal Investigator: Ting Bao, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05458284    
Other Study ID Numbers: 22-197
First Posted: July 14, 2022    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Acupuncture
Peripheral Neuropathy
22-197
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases