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

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.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• HER2-Negative Breast Carcinoma
• Hormone Receptor-Positive Breast Carcinoma

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

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Demetria Smith-Graziani, MD,MPH · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-12

Primary Completion

2026-12-31

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations