Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer

Women with histologically confirmed primary invasive carcinoma of the breast (Stage I, II, or III w/no evidence of metastatic disease) or with histologically confirmed DCIS. Must have recovered from all side-effects of surgery; post-menopausal (>/= 12 months since last menses OR prior bilateral oophorectomy OR current use of GnRH agonist OR previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of oophorectomy is unavailable) AND FSH values consistent with institutional normal values. If under age 55, FSH levels must be obtained within 28 days prior to reg); positive for either estrogen receptor (ER) and/or progesterone receptor (PgR); currently taking third-generation aromatase inhibitor (AI) for at least 30 days prior to registration with plans to continue for at least 1 additional year. Concurrent trastuzumab (herceptin) is allowed; S1200 Brief Pain Inventory-Short Form (BPI-SF) completed within 14 days prior to registration w/worst pain score of at least 3 (on item #2) that has started or increased since starting AI therapy; Zubrod PS 0-1; two or fewer acupuncture treatments within 12 months for any reason except joint symptoms. No prior acupuncture treatment for joint symptoms at any time; must not have a severe bleeding disorder; must not have allergy to latex; must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis, gout, episodes of acute monoarticular arthritis clinically consistent with pseudogout, Paget’s disease affecting the study joint (knees/hands), history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson’s disease, hemochromatosis, alkaptonuria, or primary osteochrondromatosis; Must not have a history of bone fracture or surgery of the afflicted knees/hands within 6 months prior to reg; Must not have history of illness that might confound results of the study or pose additional risk to patient; Must not be on narcotics within 14 days of reg; Must not have received oral corticosteroids, intramuscular corticosteroids, or intra-articular steroids within 28 days prior to reg; Must not have received topical analgesics or any other analgesics within 14 days prior to reg; Must not have received or implemented any other medical therapy, alternative therapy, or physical therapy for the treatment of joint pain/stiffness within 28 days prior to reg (therapeutic massage is allowed); Must be willing to submit blood and urine samples for serum hormones, inflammatory biomarkers, urine AI metabolites, and DNA analysis and given the option to consent to use of remaining specimens for future translational medicine studies; Must be able to complete study questionnaires in English or Spanish; No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, DCIS, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for > 5 years. Prestudy history/physical must be obtained within 180 days prior to reg.