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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks, 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "ARM I: Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) AI therapy."
  • "ARM II: Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy."
  • "After completion of study intervention, patients are followed up for 12 months or until the initiation of new antineoplastic or investigational therapy, whichever occurs first."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether in-person acupuncture (thin needles) or virtual acupressure (pressure or massage) can prevent joint pain from aromatase inhibitors, medicines that lower estrogen. It is for non-Hispanic Black women who have gone through menopause and have early-stage breast cancer that uses hormones to grow.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older.
  • Identify as a non-Hispanic Black woman.
  • Have gone through menopause: no period for at least 12 months, both ovaries and fallopian tubes removed, or hormone tests showing menopause.
  • Have stage I–III breast cancer that is hormone receptor-positive (uses hormones to grow) and HER2-negative (does not have high levels of the HER2 protein).
  • Finished all active treatments, such as surgery, chemotherapy, or radiation, at least 14 days before joining.
  • Plan to start an aromatase inhibitor as follow-up treatment.

Who can't join

  • Have breast cancer that has spread to distant parts of the body.
  • Have not gone through menopause.
  • Have had an allergic reaction to materials like those in acupuncture needles or other substances used in the study.
  • Have rheumatoid arthritis (a disease that attacks joints), multiple sclerosis (a nerve disease), or muscular dystrophy (a disease that weakens muscles).
  • Currently take or have ever taken a cancer medicine called a CDK 4/6 inhibitor.
  • Have taken an aromatase inhibitor before surgery.
  • Have taken an aromatase inhibitor as follow-up treatment for more than 14 days.
  • Had acupuncture within 60 days before the study starts.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (4)

GA