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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458284
• Other study ID #: 22-197
• Status: Recruiting
• Phase: Phase 2
• Start date: July 11, 2022
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Wanqing Iris Zhi, MD, PhD
• Phone: 631-623-4246
• Email: zhiw[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Peripheral Nervous System Diseases
• Taxane-Induced Peripheral Neuropathy

Intervention

Procedure:
• Real Acupuncture
Real Acupuncture weekly till taxane completion

Other:
• Sham Acupuncture
Sham Acupuncture weekly till taxane completion

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk- Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	Rockville Centre	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Gateway for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center