The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Breast Cancer, Taxane-Induced Peripheral Neuropathy
In brief
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.
Key facts
- Study ID
- NCT05458284
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 80
- Starts
- 2022-07-11
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen — Montvale, 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 Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Nassau — Rockville Centre, New York, United States
Full record on ClinicalTrials.gov
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