Using acupuncture and acupressure to reduce joint pain in Black women with early-stage breast cancer
Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer
This study is testing whether acupuncture and virtual acupressure can help reduce joint pain for Black women with early-stage breast cancer who are taking hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT06534125 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of in-person acupuncture and virtual acupressure therapy in preventing joint pain associated with aromatase inhibitors in Non-Hispanic Black postmenopausal women diagnosed with early-stage hormone receptor-positive breast cancer. Participants will be randomized into three groups: one receiving in-person acupuncture, another using virtual acupressure, and a control group receiving standard care. The study aims to assess not only the reduction in pain severity but also the adherence to aromatase inhibitor therapy and the overall satisfaction with the interventions. Additionally, focus groups will gather qualitative data on barriers and facilitators to completing the therapies.
Who should consider this trial
Good fit: Ideal candidates are Non-Hispanic Black postmenopausal women aged 18 and older with stage I-III hormone receptor-positive breast cancer who are about to start aromatase inhibitor therapy.
Not a fit: Patients with metastatic breast cancer, premenopausal women, or those with certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve the quality of life for patients by reducing joint pain and increasing adherence to life-saving breast cancer treatments.
How similar studies have performed: Other studies have shown promising results with acupuncture and acupressure for pain management, but this specific approach targeting this demographic is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Self-identified Non-Hispanic Black woman * Postmenopausal status (\>= 12 months since last menstrual period, history of bilateral salpingo-oophorectomy, or estradiol, follicle-stimulating hormone \[FSH\], and luteinizing hormone \[LH\] levels consistent with menopause) * Diagnosed with stage I-III HR+/HER2 negative (-) breast cancer * Completed all phases of active therapy (e.g. surgery, chemotherapy, and/or radiation) at least 14 days before study enrollment * Planned to start adjuvant AI Exclusion Criteria: * Diagnosed with metastatic breast cancer * Premenopausal status * History of allergic reactions attributed to compounds of similar chemical or biologic composition to acupuncture needles or other agents used in study * Diagnosis of rheumatoid arthritis, multiple sclerosis, or muscular dystrophy * A history of or current CDK 4/6 inhibitor use * A history of neoadjuvant AI use * Use of adjuvant AI \> 14 days * Received acupuncture within 60 days prior to start of study
Where this trial is running
Atlanta, Georgia and 3 other locations
- Grady Health System — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Demetria Smith-Graziani, MD,MPH — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Demetria Smith-Graziani, MD, MPH
- Email: demetria.joy.smith-graziani@emory.edu
- Phone: 404-712-4834
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.