Breast Cancer Clinical Trial
The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment
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.
Full 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.
Eligibility 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 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 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
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