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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Procedure Acupressure Therapy
  Undergo self-administered acupressure therapy to planned pressure points
• Device Acupuncture Therapy
  Undergo acupuncture therapy with acupuncture needles applied to planned pressure points
• Drug Aromatase Inhibition Therapy
  Receive SOC AI therapy
• Other Discussion
  Ancillary studies
• Other Survey Administration
  Ancillary studies

Primary outcome measures

• Brief pain inventory (BPI) pain severity score [Time frame: Baseline to 6 months after aromatase inhibitor (AI) start]
• Incidence of arthralgias [Time frame: Baseline to 6 months after AI start]

Secondary outcome measures (7)

• Pain severity [Time frame: Baseline to 6 months after starting study intervention]
• Incidence of arthralgias [Time frame: Baseline to 6 months after starting study intervention]
• AI adherence [Time frame: Baseline to 6 months after starting study intervention]
• Symptom burden [Time frame: Baseline to 6 months after starting study intervention]
• Intervention completion rate [Time frame: At 6 months after starting study intervention]
• Participant satisfaction rate [Time frame: At 6 months after starting study intervention]
• Perceived difficulty of completing study intervention [Time frame: At 6 months after starting study intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 4 centers

• Grady Health System — Atlanta
• Emory University Hospital Midtown — Atlanta
• Emory University Hospital/Winship Cancer Institute — Atlanta
• Emory Saint Joseph's Hospital — Atlanta

Identifiers

NCT: NCT06534125 · STUDY00007393 · NCI-2024-04392 · STUDY00007393 · WINSHIP6156-24 · P30CA138292

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗