Recruiting

Acutherapy

Sponsor:

Emory University

Code:

NCT06534125

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

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acupressure Therapy

Acupuncture Therapy

Aromatase Inhibition Therapy

Discussion

Survey Administration

Study Details

Brief 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

Study ID

NCT06534125

Start date

Dec 12, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (acupuncture, AI therapy)

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) aromatase inhibitor (AI) therapy.

experimental: Arm II (acupressure, AI therapy)

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.

active comparator: Arm III (AI therapy)

Patients receive SOC AI therapy.

Interventions

Acupressure Therapy

Undergo self-administered acupressure therapy to planned pressure points

Acupuncture Therapy

Undergo acupuncture therapy with acupuncture needles applied to planned pressure points

Aromatase Inhibition Therapy

Receive SOC AI therapy

Discussion

Ancillary studies

Survey Administration

Ancillary studies

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Principal Investigator:

Demetria Smith-Graziani, MD, MPH

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Principal Investigator:

Demetria Smith-Graziani, MD, MPH

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Demetria Smith-Graziani, MD, MPH

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Principal Investigator:

Demetria Smith-Graziani, MD, MPH

More Information

Sponsor

Emory University

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • Disparities
  • Health Equity
  • Health Services

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-29.