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

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Acupressure Therapy — PROCEDURE
  Undergo self-administered acupressure therapy to planned pressure points
• Acupuncture Therapy — DEVICE
  Undergo acupuncture therapy with acupuncture needles applied to planned pressure points
• Aromatase Inhibition Therapy — DRUG
  Receive SOC AI therapy
• Discussion — OTHER
  Ancillary studies
• Survey Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Dec 12, 2024

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (acupuncture, AI therapy)
  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.
• Experimental: Arm II (acupressure, AI therapy)
  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.
• Active Comparator: Arm III (AI therapy)
  Patients receive SOC AI therapy.

Primary Outcome Measure

Brief pain inventory (BPI) pain severity score [ Time Frame: Baseline to 6 months after aromatase inhibitor (AI) start ]

Central Contacts

• Demetria Smith-Graziani, MD, MPH
  404-712-4834
  [email protected]

Locations (4)

Find similar trials in Atlanta, GA

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