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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06534125
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Emory University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Demetria Smith-Graziani, MD,MPH
Principal Investigator Affiliation Emory University Hospital/Winship Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Arms & Interventions

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

Procedure: - Acupressure Therapy

Undergo self-administered acupressure therapy to planned pressure points

Device: - Acupuncture Therapy

Undergo acupuncture therapy with acupuncture needles applied to planned pressure points

Drug: - Aromatase Inhibition Therapy

Receive SOC AI therapy

Other: - Discussion

Ancillary studies

Other: - Survey Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Grady Health System, Atlanta, Georgia

Status

Recruiting

Address

Grady Health System

Atlanta, Georgia, 30303

Site Contact

Ashley Trumbull

[email protected]

404-778-3969

Emory University Hospital Midtown, Atlanta, Georgia

Status

Recruiting

Address

Emory University Hospital Midtown

Atlanta, Georgia, 30308

Site Contact

Ashley Trumbull

[email protected]

404-778-3969

Atlanta, Georgia

Status

Recruiting

Address

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Site Contact

Ashley Trumbull

[email protected]

404-778-3969

Emory Saint Joseph's Hospital, Atlanta, Georgia

Status

Not yet recruiting

Address

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

Site Contact

Ashley Trumbull

[email protected]

404-712-4834