This clinical trial evaluates if in-person acupuncture or virtual acupressure therapy prevents aromatase inhibitor-associated arthralgias (AIAA) in Non-Hispanic Black postmenopausal women with stage I-III (early-stage) hormone receptor positive (HR+) breast cancer. Aromatase inhibitor (AI) therapy uses drugs that prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. AI therapy is a type of hormone therapy for 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 AIAA in Non-Hispanic Black postmenopausal women with early-stage HR+ breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06534125.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital MidtownStatus: Active
Contact: Demetria Smith-Graziani
Phone: 404-712-4834
Emory Saint Joseph's HospitalStatus: Approved
Contact: Demetria Smith-Graziani
Phone: 404-712-4834
Grady Health SystemStatus: Active
Contact: Demetria Smith-Graziani
Phone: 404-712-4834
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Demetria Smith-Graziani
Phone: 404-712-4834
PRIMARY OBJECTIVE:
I. To determine if initiation of in-person acupuncture or virtual acupressure sessions prior to AI will reduce the severity and incidence of 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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorDemetria Smith-Graziani
