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Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer

Sponsored by Emory University

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.

PRIMARY OBJECTIVE: I. To determine if initiation of in-person acupuncture or virtual acupressure sessions within 2 weeks of starting aromatase inhibitors (AI) will reduce the severity and incidence of AI-associated arthralgias (AIAA) among non-Hispanic Black postmenopausal women with stage I-III hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer at 6 months after starting adjuvant AI therapy. SECONDARY OBJECTIVES: I. To compare the efficacy of acupuncture to the efficacy of acupressure among the study population. II. To determine if acupuncture or acupressure will increase AI adherence (secondary endpoint) among the study population at 6 months after starting adjuvant AI therapy. III. To evaluate the acceptance, satisfaction, convenience, …

Where this study is enrolling (4)

Who can participate

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

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Trial data sourced from ClinicalTrials.gov.