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Behavioural Intervention

Arm II (acupressure, AI therapy) for Breast Cancer

N/A
Waitlist Available
Led By Demetria Smith-Graziani, MD,MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age ≥ 18 years
* Self-identified Non-Hispanic Black woman
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months after starting study intervention
Awards & highlights

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.

Who is the study for?
This trial is for Non-Hispanic Black postmenopausal women with stage I-III hormone receptor positive breast cancer who are taking aromatase inhibitors. It aims to help those suffering from joint pain due to their medication. Participants should not have started AI therapy more than a month ago and must be able to attend in-person or virtual sessions.
What is being tested?
The study tests if acupuncture (inserting thin needles into the skin) or acupressure (applying pressure on specific body points) can prevent joint pain caused by aromatase inhibitor therapy in participants. The effectiveness of these complementary therapies will be compared through surveys and discussions.
What are the potential side effects?
Potential side effects from acupuncture may include slight bleeding, bruising, or soreness at needle sites. Acupressure might cause temporary discomfort or tenderness at pressure points. Both methods aim to reduce pain rather than cause it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months after starting study intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months after starting study intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brief pain inventory (BPI) pain severity score
Secondary study objectives
AI adherence
Incidence of arthralgias
Intervention completion rate
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (acupressure, AI therapy)Experimental Treatment4 Interventions
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.
Group II: Arm I (acupuncture, AI therapy)Experimental Treatment4 Interventions
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.
Group III: Arm III (AI therapy)Active Control2 Interventions
Patients receive SOC AI therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aromatase Inhibition Therapy
2011
Completed Phase 3
~3500
Acupuncture Therapy
2018
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,665 Previous Clinical Trials
2,574,935 Total Patients Enrolled
29 Trials studying Breast Cancer
7,528 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,666 Previous Clinical Trials
4,132,977 Total Patients Enrolled
51 Trials studying Breast Cancer
8,265 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,789 Previous Clinical Trials
40,986,145 Total Patients Enrolled
945 Trials studying Breast Cancer
1,544,023 Patients Enrolled for Breast Cancer
~100 spots leftby Dec 2025