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NCT Number: NCT06534125

Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in 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.

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Key information

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupressure therapy

Procedure

Undergo self-administered acupressure therapy to planned pressure points

Other names: Acupressure, Ischemic Compression

Acupuncture Therapy

Device

Undergo acupuncture therapy with acupuncture needles applied to planned pressure points

Other names: Acupuncture

Aromatase Inhibition Therapy

Drug

Receive SOC AI therapy

Other names: Aromatase Inhibition

Discussion

Other

Ancillary studies

Other names: Discuss

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Pain severity

    Time frame: Baseline to 6 months after starting study intervention

    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.

  2. Incidence of arthralgias

    Time frame: Baseline to 6 months after starting study intervention

    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.

  3. AI adherence

    Time frame: Baseline to 6 months after starting study intervention

    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.

  4. Symptom burden

    Time frame: Baseline to 6 months after starting study intervention

    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.

  5. Intervention completion rate

    Time frame: At 6 months after starting study intervention

    Will track the number of acupuncture or acupressure sessions that study participants successfully complete.

  6. Participant satisfaction rate

    Time frame: At 6 months after starting study intervention

    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.

  7. Perceived difficulty of completing study intervention

    Time frame: At 6 months after starting 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Demetria Smith-Graziani, MD, MPH

CONTACT

[email protected]

404-712-4834

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Bristol-Myers Squibb
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 2, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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