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

NCT06534125 | Recruiting DMC FDA Device

• 4 other identifiers: STUDY00007393NCI-2024-04392WINSHIP6156-24P30CA138292
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

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

Keywords

Disparities; Health Equity; Health Services

Outcome Measures

Primary Outcomes (2)

• Brief pain inventory (BPI) pain severity score

  Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI severity score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point versus (vs) \< 1 point increase in pain severity) in order to determine the incidence of aromatase inhibitor-associated arthralgias (AIAA) and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.

  Baseline to 6 months after aromatase inhibitor (AI) start

• Incidence of arthralgias

  Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point vs \< 1 point increase in pain severity) in order to determine the incidence of AIAA and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.

  Baseline to 6 months after AI start

Secondary Outcomes (7)

• Pain severity

  Baseline to 6 months after starting study intervention

• Incidence of arthralgias

  Baseline to 6 months after starting study intervention

• AI adherence

  Baseline to 6 months after starting study intervention

• Symptom burden

  Baseline to 6 months after starting study intervention

• Intervention completion rate

  At 6 months after starting study intervention

Study Arms (3)

Arm I (acupuncture, AI therapy)

EXPERIMENTAL

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.

Device: Acupuncture Therapy; Drug: Aromatase Inhibition Therapy; Other: Discussion; Other: Survey Administration

Arm II (acupressure, AI therapy)

EXPERIMENTAL

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.

Procedure: Acupressure Therapy; Drug: Aromatase Inhibition Therapy; Other: Discussion; Other: Survey Administration

Arm III (AI therapy)

ACTIVE COMPARATOR

Patients receive SOC AI therapy.

Drug: Aromatase Inhibition Therapy; Other: Survey Administration

Interventions

Acupressure Therapy PROCEDURE

Undergo self-administered acupressure therapy to planned pressure points

Also known as: Acupressure, Ischemic Compression

Arm II (acupressure, AI therapy)

Acupuncture Therapy DEVICE

Undergo acupuncture therapy with acupuncture needles applied to planned pressure points

Also known as: Acupuncture

Arm I (acupuncture, AI therapy)

Aromatase Inhibition Therapy DRUG

Receive SOC AI therapy

Also known as: Aromatase Inhibition

Arm I (acupuncture, AI therapy); Arm II (acupressure, AI therapy); Arm III (AI therapy)

Discussion OTHER

Ancillary studies

Also known as: Discuss

Arm I (acupuncture, AI therapy); Arm II (acupressure, AI therapy)

Survey Administration OTHER

Ancillary studies

Arm I (acupuncture, AI therapy); Arm II (acupressure, AI therapy); Arm III (AI therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Bristol-Myers Squibb: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

Interventions

Acupressure; Acupuncture Therapy; Aromatase Inhibitors

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Demetria Smith-Graziani, MD,MPH

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Demetria Smith-Graziani, MD, MPH

CONTACT

404-712-4834; demetria.joy.smith-graziani@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (4)