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

RecruitingNAAges 18 Years - anyFemaleEmory University
NCT06534125 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
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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What it tests

  • Acupressure Therapy
  • Acupuncture Therapy
  • Aromatase Inhibition Therapy
  • Discussion
  • Survey Administration
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Where

4 sites
Grady Health System
Atlanta, United States
Emory University Hospital Midtown
Atlanta, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Emory Saint Joseph's Hospital
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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