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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Other, Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Emory Saint Joseph's Hospital
NOT_YET_RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Grady Health System
RECRUITING
Atlanta
Contact Information
Primary
Demetria Smith-Graziani, MD, MPH
demetria.joy.smith-graziani@emory.edu
404-712-4834
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb, National Cancer Institute (NCI)
Leads: Emory University

This content was sourced from clinicaltrials.gov