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Official Title

Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer

Sponsor
Emory University
Enrollment
150
Timeline
Dec 2024 → Dec 2026
About This Study

This clinical trial evaluates if in-person acupuncture or virtual acupressure therapy prevents aromatase inhibitor-associated joint pain in Non-Hispanic Black postmenopausal women with stage I-III (early-stage) hormone receptor positive (HR+) breast cancer. Aromatase inhibitors (AI) are medications that prevent the formation of the hormone estrogen. They are used in the treatment of postmenopausal women who have hormone-dependent breast cancer. AI therapy prolongs life among patients with early-stage HR+ breast cancer. Many postmenopausal women stop AI therapy early due to debilitating joint pain (arthralgias). Non-Hispanic Black women are more likely to experience side effects and stop their hormonal therapy compared to Non-Hispanic white women. Acupuncture therapy involves inserting thin needles through the skin at specific points on the body to control pain. Acupressure therapy uses the application of pressure or localized massage to specific sites on the body to control symptoms such as pain. Acupuncture and acupressure are types of complementary and alternative medicine. Undergoing in-person acupuncture or participating in virtual acupressure may prevent AI-associated arthralgias (AIAA) in Non-Hispanic Black postmenopausal women with early-stage HR+ breast cancer.

Eligibility Criteria

Inclusion Criteria

  • 1Age ≥ 18 years
  • 2Self-identified Non-Hispanic Black woman
  • 3Postmenopausal 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)
  • 4Diagnosed with stage I-III HR+/HER2 negative (-) breast cancer
  • 5Completed all phases of active therapy (e.g. surgery, chemotherapy, and/or radiation) at least 14 days before study enrollment
  • 6Planned to start adjuvant AI

Exclusion Criteria

  • 1Diagnosed with metastatic breast cancer
  • 2Premenopausal status
  • 3History of allergic reactions attributed to compounds of similar chemical or biologic composition to acupuncture needles or other agents used in study
  • 4Diagnosis of rheumatoid arthritis, multiple sclerosis, or muscular dystrophy
  • 5A history of or current CDK 4/6 inhibitor use
  • 6A history of neoadjuvant AI use
  • 7Use of adjuvant AI \> 14 days
  • 8Received acupuncture within 60 days prior to start of study

Locations

4 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →