Actively Recruiting
Preventing Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women With Early-Stage Hormone Receptor-Positive Breast Cancer
Led by Emory University · Updated on 2026-01-29
150
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying if in-person acupuncture or virtual acupressure can prevent joint pain caused by aromatase inhibitor (AI) therapy in Non-Hispanic Black postmenopausal women with early-stage hormone receptor-positive breast cancer. Aromatase inhibitors help treat this type of breast cancer by lowering estrogen but often cause joint pain that makes many women stop treatment early. This trial aims to reduce that pain and improve adherence to AI therapy in this population. Participants are randomly assigned to one of three groups: one group receives in-person acupuncture sessions twice weekly for six weeks, then once weekly for six weeks along with standard AI therapy; another group performs self-administered virtual acupressure with the same schedule alongside AI therapy; the third group receives only the standard AI therapy. After completing these interventions, participants are followed for 12 months or until they start new cancer treatments. During the study, researchers measure joint pain severity using the Brief Pain Inventory and track the incidence of joint pain over six months. They also assess AI therapy adherence, symptom burden, satisfaction with the interventions, and ease of completing the therapies. Participants may join focus groups to discuss barriers and facilitators to treatment. Safety and outcomes are monitored throughout the trial's duration.
CONDITIONS
Brief Title
Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Self-identified Non-Hispanic Black woman
- Postmenopausal status defined as 12 months or more since last menstrual period, history of bilateral salpingo-oophorectomy, or hormone levels consistent with menopause
- Diagnosed with stage I-III hormone receptor-positive, HER2-negative breast cancer
- Completed all active therapy phases (surgery, chemotherapy, radiation) at least 14 days before enrollment
- Planned to start adjuvant aromatase inhibitor therapy
You will not qualify if you...
- Diagnosed with metastatic breast cancer
- Premenopausal status
- History of allergic reactions to acupuncture needles or similar compounds
- Diagnosis of rheumatoid arthritis, multiple sclerosis, or muscular dystrophy
- History of or current use of CDK 4/6 inhibitors
- History of neoadjuvant aromatase inhibitor use
- Use of adjuvant aromatase inhibitors for more than 14 days
- Received acupuncture within 60 days prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants start aromatase inhibitor therapy and are randomized to receive either in-person acupuncture twice weekly for 6 weeks then weekly for 6 weeks, self-administered virtual acupressure with the same schedule, or aromatase inhibitor therapy alone.
Twice weekly visits for 6 weeks then weekly visits for 6 weeks for acupuncture arm; self-administered virtual sessions for acupressure arm; visits as per standard care for aromatase inhibitor only arm
Duration - Up to 12 months
Participants are followed for up to 12 months after completing the intervention to monitor outcomes and adherence to aromatase inhibitor therapy.
Visits as scheduled for up to 12 months after treatment completion
Trial Site Locations
Total: 4 locations
1
Grady Health System
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
Research Team
D
Demetria Smith-Graziani, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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