Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients
- To evaluate the efficacy of acupuncture in reducing pain, defined by improvements in
overall WOMAC score at 6 weeks, in post-menopausal women with breast cancer and
aromatase inhibitor (AI)-associated arthralgia.
- To identify biologic correlates to acupuncture efficacy in this specific syndrome of
- To evaluate the efficacy of acupuncture in these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients undergo acupuncture for 20-30 minutes, on the appropriate pain points
on the anterior portion of the body alternating with posterior portion of the body,
thrice weekly for 2 weeks and then twice weekly for 3 weeks.
- Arm II: Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics,
acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross
over to arm I.
Patients are assessed periodically for improvement in pain, menopausal symptoms, and overall
quality of life by the WOMAC, Brief Pain Inventory, and FACT-ES questionnaires.
Blood samples are collected at baseline, 6 weeks, 3 months, and 6 months for biomarker
studies of brain-derived neurotrophic factor and serotonin-transporter gene polymorphisms
levels by ELISA.
After completion of study therapy, patients are followed at 1 week, 6 weeks, 3 months, and 6
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Improvement in pain, as defined by the WOMAC global score at 6 weeks
Leona B. Downey, MD
University of Arizona
United States: Federal Government