Acupuncture, Sham Acupuncture, or Wait List for Joint Symptoms Related to Aromatase Inhibitors in Patients with Early-Stage Breast Cancer
- Patients must be women with histologically confirmed primary invasive carcinoma of the breast (stage I, II, or III) with no evidence of metastatic disease (M0) or with histologically confirmed ductal carcinoma in situ (DCIS); if patient has undergone breast cancer surgery, she must have recovered from all side-effects of surgery
- Patients must be postmenopausal, as defined by at least one of the following: * >= 12 months since the last menstrual period OR * Prior bilateral oophorectomy OR * Current use of a GnRH agonist OR * Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND FSH values consistent with the institutional normal values for the postmenopausal state; if patient is under the age of 55, FSH levels must be obtained within 28 days prior to registration
- Patients must be positive for either estrogen receptor (ER) and/or progesterone receptor (PgR) as determined by institutional standard
- Patients must currently be taking a third-generation aromatase inhibitor (AI) – anastrozole, letrozole, or exemestane for at least the previous 30 days prior to registration with plans to continue for at least an additional 1 year after registration; patients may have switched AIs provided that they have been on a stable dose for at least 30 days; concurrent trastuzumab (Herceptin) is allowed
- Patients must have completed the S1200 Brief Pain Inventory-Short Form (BPI-SF) within 14 days prior to registration; patients must have a worst pain score of at least 3 on the Brief Pain Inventory (item #2) that has started or increased since starting AI therapy
- Patients must have a Zubrod performance status of 0 to 1
- Patients must have had two or fewer acupuncture treatments within the past 12 months for any reason except for joint symptoms; patients must not have had prior acupuncture treatment for joint symptoms at any time
- Patients must not have a severe bleeding disorder
- Patients must not have an allergy to latex
- Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), gout, episodes of acute monoarticular arthritis clinically consistent with pseudogout, Paget's disease affecting the study joint (knees/hands), a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson's disease, hemochromatosis, alkaptonuria, or primary osteochondromatosis
- Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration
- Patients must not have a history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient
- Patients must not be on narcotics within 14 days of registration
- Patients must not have received oral corticosteroids, intramuscular corticosteroids, or intra-articular steroids for joint symptoms within 28 days prior to registration
- Patients must not have received topical analgesics (e.g., capsaicin preparations) or any other analgesics (e.g., opiates, tramadol, with the exception of nonsteroidal anti-inflammatory drugs [NSAIDs], combination NSAIDs, and acetaminophen) within 14 days prior to registration
- Patients 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 registration; therapeutic massage is allowed
- Patients 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, ductal carcinoma in situ [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 and physical must be obtained within 180 days prior to registration
- Patients must be willing to submit blood and urine samples for serum hormones (estradiol, FSH, LH), inflammatory biomarkers (serum TNFalpha, IL-6, IL-12, CRP and urine CTX-II),urine AI metabolites, and deoxyribonucleic acid (DNA) analysis (CYP19A1), and must be given the option to consent to use of remaining specimens for future translational medicine studies; baseline samples must be obtained prior to beginning intervention
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the database
South San Francisco
Salt Lake City
I. To determine whether true acupuncture administered twice weekly for 6 weeks (8-12 sessions) compared to sham acupuncture and waitlist control causes a significant reduction in joint pain related to aromatase inhibitors (AIs) in women with early-stage breast cancer as measured by the Brief Pain Inventory-Short Form (BPI-SF) worst pain score at 6 weeks.
I. To investigate the effects of true acupuncture administered twice weekly for 6 weeks (8-12 sessions) followed by 6 weekly treatments (4-6 sessions) of maintenance (12-18 sessions total over 12 weeks) compared to sham acupuncture and waitlist control in this study population.
II. To evaluate the effects of acupuncture on the BPI-SF worst pain, worst stiffness, pain severity, and pain-related interference scores at 6, 12, 16, 20, 24, and 52 weeks.
III. To evaluate the effects of acupuncture on Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index (pain, stiffness, and function) for the hips and knees at 6, 12, 24, and 52 weeks.
IV. To evaluate the effects of acupuncture on Modified-Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) (pain, stiffness, and function) at 6, 12, 24, and 52 weeks.
V. To evaluate the effects of acupuncture on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Impact-Short Form (PROMIS PI-SF) at 6, 12, 24, and 52 weeks.
VI. To evaluate the effects of acupuncture on quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at 6, 12, 24, and 52 weeks.
VII. To evaluate the effects of acupuncture on functional testing with grip strength and “Timed Get Up and Go” (TGUG) test at 6, 12, 24, and 52 weeks.
VIII. To evaluate the effects of acupuncture on analgesic and opioid use at 2, 4, 6, 12, 16, 20, 24, and 52 weeks.
IX. To evaluate the effects of acupuncture on self-reported AI adherence at 12, 24, and 52 weeks.
X. To assess AI adherence via urine AI metabolites at baseline, 24, and 52 weeks.
XI. To evaluate the effects of acupuncture on serum hormones (estradiol, follicle stimulating hormone [FSH], luteinizing hormone [LH]) and inflammatory biomarkers (serum tumor necrosis factors [TNF] alpha, interleukin [IL]-6, IL-12, C-reactive protein [CRP], and urine c-telopeptides of type II collagen [CTX-II]) at 6, 12, and 24 weeks.
XII. To evaluate whether polymorphisms in cytochrome P450, family 19, subfamily A, polypeptide 1 (CYP19A1) aromatase gene predict severity of AI-related joint symptoms.
XIII. To assess the safety and tolerability of acupuncture in this study population.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.
Arm II: Patients receive sham acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.
Arm III: Patients are assigned to a waiting list for 12 weeks.
After completion of study treatment, patients are followed up at 24 and 52 weeks.
Trial Phase Phase III
Trial Type Supportive care
Dawn Lauryn Hershman
- Primary ID S1200
- Secondary IDs NCI-2012-00251, SWOG-S1200, CDR0000725249
- Clinicaltrials.gov ID NCT01535066