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Acupuncture and Acupressure for Joint Pain from Aromatase Inhibitors

This study is for Non-Hispanic Black postmenopausal women with early-stage (Stage I-III) hormone receptor-positive (HR+) and HER2-negative breast cancer. It explores whether acupuncture or acupressure therapy can help prevent or reduce joint pain (arthralgias) caused by aromatase inhibitor (AI) medications. Aromatase inhibitors are used to treat hormone-dependent breast cancer by lowering estrogen levels, but they can cause joint pain that sometimes leads women to stop their treatment early. The study aims to see if these therapies can improve joint pain and help women continue their AI treatment. Researchers will measure your pain severity and how often you experience joint pain over 6 months after starting AI therapy.

Study design
This interventional study plans to enroll 150 participants. You will be randomly assigned to receive either in-person acupuncture, virtual acupressure, or standard aromatase inhibitor therapy.
What's involved
You will undergo self-administered acupressure therapy or acupuncture therapy. You will also receive standard aromatase inhibitor therapy and complete surveys.
Compensation
Not stated in the trial record.
Follow-up
Your pain severity and incidence of joint pain will be measured for 6 months after starting aromatase inhibitor therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06534125

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

Recruiting
NAAges 18+InterventionalSupportive care
Emory University
~150 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:Acupressure TherapyAcupuncture TherapyAromatase Inhibition TherapyDiscussionSurvey Administration

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brief pain inventory (BPI) pain severity score
Measured over Baseline to 6 months after aromatase inhibitor (AI) start
+1 more outcome measured

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

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Where it's being run

4 sites across 1 states
Georgia4

Study leadership

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

Who to contact

Demetria Smith-Graziani, MD, MPH
[email protected]
404-712-4834
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Brief pain inventory (BPI) pain severity scoreBaseline to 6 months after aromatase inhibitor (AI) start

    Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI severity score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point versus (vs) \< 1 point increase in pain severity) in order to determine the incidence of aromatase inhibitor-associated arthralgias (AIAA) and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.

  • Incidence of arthralgiasBaseline to 6 months after AI start

    Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point vs \< 1 point increase in pain severity) in order to determine the incidence of AIAA and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.