RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-12
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06534125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Self-identified Non-Hispanic Black woman
  3. * 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)
  4. * Diagnosed with stage I-III HR+/HER2 negative (-) breast cancer
  5. * Completed all phases of active therapy (e.g. surgery, chemotherapy, and/or radiation) at least 14 days before study enrollment
  6. * Planned to start adjuvant AI
  1. * Diagnosed with metastatic breast cancer
  2. * Premenopausal status
  3. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to acupuncture needles or other agents used in study
  4. * Diagnosis of rheumatoid arthritis, multiple sclerosis, or muscular dystrophy
  5. * A history of or current CDK 4/6 inhibitor use
  6. * A history of neoadjuvant AI use
  7. * Use of adjuvant AI \> 14 days
  8. * Received acupuncture within 60 days prior to start of study

Contacts and Locations

Study Contact

Demetria Smith-Graziani, MD, MPH
CONTACT
404-712-4834
demetria.joy.smith-graziani@emory.edu

Principal Investigator

Demetria Smith-Graziani, MD,MPH
PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute

Study Locations (Sites)

Grady Health System
Atlanta, Georgia, 30303
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States

Collaborators and Investigators

Sponsor: Emory University

  • Demetria Smith-Graziani, MD,MPH, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-12-12
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Disparities
  • Health Equity
  • Health Services

Additional Relevant MeSH Terms

  • 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