Trial Title:
Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer
NCT ID:
NCT06534125
Condition:
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
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Arthralgia
Aromatase Inhibitors
Conditions: Keywords:
Disparities
Health Equity
Health Services
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Acupressure Therapy
Description:
Undergo self-administered acupressure therapy to planned pressure points
Arm group label:
Arm II (acupressure, AI therapy)
Other name:
Acupressure
Other name:
Ischemic Compression
Intervention type:
Device
Intervention name:
Acupuncture Therapy
Description:
Undergo acupuncture therapy with acupuncture needles applied to planned pressure points
Arm group label:
Arm I (acupuncture, AI therapy)
Other name:
Acupuncture
Intervention type:
Drug
Intervention name:
Aromatase Inhibition Therapy
Description:
Receive SOC AI therapy
Arm group label:
Arm I (acupuncture, AI therapy)
Arm group label:
Arm II (acupressure, AI therapy)
Arm group label:
Arm III (AI therapy)
Other name:
Aromatase Inhibition
Intervention type:
Other
Intervention name:
Discussion
Description:
Ancillary studies
Arm group label:
Arm I (acupuncture, AI therapy)
Arm group label:
Arm II (acupressure, AI therapy)
Other name:
Discuss
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (acupuncture, AI therapy)
Arm group label:
Arm II (acupressure, AI therapy)
Arm group label:
Arm III (AI therapy)
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Grady Health System
Address:
City:
Atlanta
Zip:
30303
Country:
United States
Contact:
Last name:
Ashley Trumbull
Phone:
404-778-3969
Email:
ashley.lynn.trumbull@emory.edu
Contact backup:
Last name:
Demetria Smith-Graziani, MD, MPH
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Contact:
Last name:
Ashley Trumbull
Phone:
404-778-3969
Email:
ashley.lynn.trumbull@emory.edu
Contact backup:
Last name:
Demetria Smith-Graziani, MD, MPH
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Contact:
Last name:
Ashley Trumbull
Phone:
404-778-3969
Email:
ashley.lynn.trumbull@emory.edu
Contact backup:
Last name:
Demetria Smith-Graziani, MD, MPH
Facility:
Name:
Emory Saint Joseph's Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Contact:
Last name:
Ashley Trumbull
Phone:
404-712-4834
Email:
ashley.lynn.trumbull@emory.edu
Contact backup:
Last name:
Demetria Smith-Graziani, MD, MPH
Start date:
November 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06534125
