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

Last updated: January 23, 2025
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Muscle Pain

Carcinoma

Treatment

Acupuncture Therapy

Acupressure Therapy

Survey Administration

Clinical Study ID

NCT06534125
STUDY00007393
P30CA138292
NCI-2024-04392
WINSHIP6156-24
STUDY00007393
  • Ages > 18
  • Female

Study Summary

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

Inclusion Criteria:

  • Age ≥ 18 years

  • Self-identified Non-Hispanic Black woman

  • Postmenopausal status (>= 12 months since last menstrual period, history ofbilateral 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/orradiation) at least 14 days before study enrollment

  • Planned to start adjuvant AI

Exclusion

Exclusion Criteria:

  • Diagnosed with metastatic breast cancer

  • Premenopausal status

  • History of allergic reactions attributed to compounds of similar chemical orbiologic 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 Design

Total Participants: 150
Treatment Group(s): 5
Primary Treatment: Acupuncture Therapy
Phase:
Study Start date:
December 12, 2024
Estimated Completion Date:
December 31, 2026

Study Description

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, accessibility, and perceptions of in-person acupuncture and virtual acupressure.

IV. To conduct 4 focus groups of 6-12 non-Hispanic Black women who receive 12 weeks of acupuncture or acupressure and collect and analyze qualitative data about barriers and facilitators to completing each intervention, transportation concerns, and ease or difficulty of completing each intervention.

OUTLINE: Patients are randomized to 1 of 3 arms.

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.

ARM III: Patients 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.

Connect with a study center

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Emory University Hospital Midtown

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Grady Health System

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

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