Clinical trial NCT06534125: Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer
Official title: Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: Disparities
Health Equity
Health Services
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: National Cancer Institute (NCI)
First posted: 2024-08-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVE:

I. To determine if initiation of in-person acupuncture or virtual acupressure sessions within 2 weeks of starting aromatase inhibitors (AI) will reduce the severity and incidence of AI-associated arthralgias (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.

Eligibility criteria: 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

Primary outcomes:
measure: Brief pain inventory (BPI) pain severity score
timeFrame: Baseline to 6 months after aromatase inhibitor (AI) start
measure: Incidence of arthralgias
timeFrame: Baseline to 6 months after AI start
Secondary outcomes:
measure: Pain severity
timeFrame: Baseline to 6 months after starting study intervention
measure: Incidence of arthralgias
timeFrame: Baseline to 6 months after starting study intervention
measure: AI adherence
timeFrame: Baseline to 6 months after starting study intervention
measure: Symptom burden
timeFrame: Baseline to 6 months after starting study intervention
measure: Intervention completion rate
timeFrame: At 6 months after starting study intervention
measure: Participant satisfaction rate
timeFrame: At 6 months after starting study intervention
measure: Perceived difficulty of completing study intervention
timeFrame: At 6 months after starting study intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Demetria Smith-Graziani, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: