Clinical trial · Interventional
Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer
Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| HER2-Negative Breast Carcinoma | HER2-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hormone Receptor-Positive Breast Carcinoma | Hormone Receptor-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupressure Therapy | Procedure | — | UNRESOLVED |
| Acupuncture Therapy | Device | — | UNRESOLVED |
| Aromatase Inhibition Therapy | Drug | — | UNRESOLVED |
| Discussion | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (acupuncture, AI therapy)
- description
- 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.
- interventionNames
- Device: Acupuncture Therapy
- Drug: Aromatase Inhibition Therapy
- Other: Discussion
- Other: Survey Administration
- type
- EXPERIMENTAL
- label
- Arm II (acupressure, AI therapy)
- description
- 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.
- interventionNames
- Procedure: Acupressure Therapy
- Drug: Aromatase Inhibition Therapy
- Other: Discussion
- Other: Survey Administration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available