Anatomic Stage I Breast Cancer AJCC v8NCT06534125
Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer
A study testing Acupressure Therapy, Acupuncture Therapy and Aromatase Inhibition Therapy in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Emory University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Acupressure Therapy, Acupuncture Therapy and Aromatase Inhibition Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Ashley Trumbull, 404-778-3969, ashley.lynn.trumbull@emory.edu
Demetria Smith-Graziani, MD, MPH
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Ashley Trumbull, 404-778-3969, ashley.lynn.trumbull@emory.edu
Demetria Smith-Graziani, MD, MPH
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Ashley Trumbull, 404-778-3969, ashley.lynn.trumbull@emory.edu
Demetria Smith-Graziani, MD, MPH
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Ashley Trumbull, 404-712-4834, ashley.lynn.trumbull@emory.edu
Demetria Smith-Graziani, MD, MPH
About this study
Official title: Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Being tested
- Acupressure Therapy, Acupuncture Therapy, Aromatase Inhibition Therapy, Discussion, Survey Administration
- Keywords
- Disparities, Health Equity, Health Services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure TherapyProcedure or surgery
Also called Acupressure, Ischemic Compression
Undergo self-administered acupressure therapy to planned pressure points
Acupuncture TherapyDevice
Also called Acupuncture
Undergo acupuncture therapy with acupuncture needles applied to planned pressure points
Aromatase Inhibition TherapyDrug
Also called Aromatase Inhibition
Receive SOC AI therapy
DiscussionOther
Also called Discuss
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (acupuncture, AI therapy) | Experimental | 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. Receives: Device: Acupuncture Therapy; Drug: Aromatase Inhibition Therapy; Other: Discussion; Other: Survey Administration |
| Arm II (acupressure, AI therapy) | Experimental | 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. Receives: Procedure: Acupressure Therapy; Drug: Aromatase Inhibition Therapy; Other: Discussion; Other: Survey Administration |
| Arm III (AI therapy) | Active comparator | Patients receive SOC AI therapy. Receives: Drug: Aromatase Inhibition Therapy; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief pain inventory (BPI) pain severity score
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.
Measured: Baseline to 6 months after aromatase inhibitor (AI) start
Incidence of arthralgias
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.
Measured: Baseline to 6 months after AI start
Secondary outcomes (7)
Pain severity
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.
Measured: Baseline to 6 months after starting study intervention
Incidence of arthralgias
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.
Measured: Baseline to 6 months after starting study intervention
AI adherence
Will be assessed by electronic medical record and patient report. Longitudinal data measured repeatedly over time will be modeled by the generalized linear model (GENMOD) with hypothesis testing on the trend of assessment change over time or probability of developing AIAA over time among the three arms.
Measured: Baseline to 6 months after starting study intervention
Symptom burden
Will be assessed by the Functional Assessment of Cancer Symptoms- Endocrine Symptoms score. The Functional Assessment of Cancer Symptoms - Endocrine Symptoms (FACT-ES) is a 46-item validated survey that assesses physical well-being, social/family well-being, emotional well-being, functional well-being, and common symptoms associated with endocrine therapy among cancer patients > 18 years old receiving endocrine treatments. Each question is on a 5-point Likert scale. A higher composite score correlates to a better quality of life.
Measured: Baseline to 6 months after starting study intervention
Intervention completion rate
Will track the number of acupuncture or acupressure sessions that study participants successfully complete.
Measured: At 6 months after starting study intervention
Participant satisfaction rate
Will be assessed by the Client Satisfaction Questionnaire (CSQ-4). Will assess the intervention impact on satisfaction level, difficulty of completing interventions, and perceived benefit of the interventions at the primary time point at weeks 24, as well as their change pattern over time. A higher score indicates more satisfaction. Will conduct 4 focus groups (2 per intervention arm) of 12 patients each, stratified by intervention type (acupuncture vs acupressure) and clinic site, which is believed to be sufficient to reach saturation of themes. For qualitative focus groups, will use conventional content analysis methods. In-depth focus groups will be audio-recorded and professionally transcribed.
Measured: At 6 months after starting study intervention
Perceived difficulty of completing study intervention
Will be assessed by the CSQ-4. Will assess the intervention impact on satisfaction level, difficulty of completing interventions, and perceived benefit of the interventions at the primary time point at weeks 24, as well as their change pattern over time. A higher score indicates more satisfaction. Will conduct 4 focus groups (2 per intervention arm) of 12 patients each, stratified by intervention type (acupuncture vs acupressure) and clinic site, which is believed to be sufficient to reach saturation of themes. For qualitative focus groups, will use conventional content analysis methods. In-depth focus groups will be audio-recorded and professionally transcribed.
Measured: At 6 months after starting study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start12 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Demetria J. Smith-Graziani, Emory University
- Investigators
- Demetria Smith-Graziani, MD,MPH, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534125
- Sponsor's protocol ID
- STUDY00007393
- Other IDs
- NCI-2024-04392, STUDY00007393, WINSHIP6156-24, P30CA138292
- Status last verified
- Jan 2026
- First submitted
- 30 Jul 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT06534125
- Acronym / sponsor ID
- STUDY00007393
- 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
- Keywords
- Disparities, Health Equity, Health Services
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, National Cancer Institute (NCI)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (acupuncture, AI therapy) | Experimental | Device: Acupuncture Therapy, Drug: Aromatase Inhibition Therapy, Other: Discussion, Other: Survey AdministrationPatients 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. |
| Arm II (acupressure, AI therapy) | Experimental | Procedure: Acupressure Therapy, Drug: Aromatase Inhibition Therapy, Other: Discussion, Other: Survey AdministrationPatients 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 (AI therapy) | Active comparator | Drug: Aromatase Inhibition Therapy, Other: Survey AdministrationPatients receive SOC AI therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure TherapyAlso: Acupressure, Ischemic CompressionUndergo self-administered acupressure therapy to planned pressure points | Procedure or surgery | Arm II (acupressure, AI therapy) |
| Acupuncture TherapyAlso: AcupunctureUndergo acupuncture therapy with acupuncture needles applied to planned pressure points | Device | Arm I (acupuncture, AI therapy) |
| Aromatase Inhibition TherapyAlso: Aromatase InhibitionReceive SOC AI therapy | Drug | Arm I (acupuncture, AI therapy), Arm II (acupressure, AI therapy), Arm III (AI therapy) |
| DiscussionAlso: DiscussAncillary studies | Other | Arm I (acupuncture, AI therapy), Arm II (acupressure, AI therapy) |
| Survey AdministrationAncillary studies | Other | Arm I (acupuncture, AI therapy), Arm II (acupressure, AI therapy), Arm III (AI therapy) |
Primary outcome
Brief pain inventory (BPI) pain severity score
Time frame: Baseline 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 arthralgias
Time frame: Baseline 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.
7 secondary outcomes
Pain severity
Time frame: Baseline to 6 months after starting study intervention
Incidence of arthralgias
Time frame: Baseline to 6 months after starting study intervention
AI adherence
Time frame: Baseline to 6 months after starting study intervention
Symptom burden
Time frame: Baseline to 6 months after starting study intervention
Intervention completion rate
Time frame: At 6 months after starting study intervention
Participant satisfaction rate
Time frame: At 6 months after starting study intervention
Perceived difficulty of completing study intervention
Time frame: At 6 months after starting study intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Demetria Smith-Graziani, MD,MPH principal investigator
Emory University Hospital/Winship Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure Therapy, Acupuncture Therapy and Aromatase Inhibition Therapy in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demetria Smith-Graziani, MD, MPH (404-712-4834, demetria.joy.smith-graziani@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief pain inventory (BPI) pain severity score (time frame: Baseline to 6 months after aromatase inhibitor (AI) start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.