Acupuncture for nerve pain from chemotherapy
Acupuncture for Taxane-Induced Peripheral Neuropathy Prevention (ATP): A Phase II Randomized, Placebo Controlled Trial
This study tests if real acupuncture can help breast cancer patients reduce nerve pain caused by chemotherapy and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05458284 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of acupuncture in preventing the worsening of taxane-induced peripheral neuropathy (TIPN) in patients undergoing chemotherapy for breast cancer. Participants will be screened weekly for TIPN and, if eligible, will be randomized to receive either real acupuncture or sham acupuncture treatments. The study aims to determine if real acupuncture can alleviate nerve pain associated with chemotherapy, thereby improving patients' quality of life during treatment.
Who should consider this trial
Good fit: Ideal candidates are English or Spanish-speaking adults aged 18 and older with early-stage breast cancer receiving taxane chemotherapy and experiencing TIPN.
Not a fit: Patients with pre-existing peripheral neuropathy or those not undergoing taxane chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological option for managing nerve pain in breast cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have shown promising results for acupuncture in managing chemotherapy-related side effects, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk- Commack — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jun Mao, MD, MSCE — Memorial Sloan Kettering Cancer Center
- Study coordinator: Jun Mao, MD, MSCE
- Email: maoj@mskcc.org
- Phone: 646-608-8552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.