S1200: Acupuncture, Sham Acupuncture, or Wait List for Joint Symptoms Related to Aromatase Inhibitors in Pts W/Early-Stage Breast Cancer
Breast Cancer, Pain
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, pain
Eligibility Criteria
DISEASE CHARACTERISTICS:
- 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); patients must have undergone modified radical mastectomy or breast-sparing surgery; patients must have recovered from all side-effects of the surgery
- Patients must be positive for 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 90 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 90 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 be willing to submit blood and urine samples for serum hormones (estradiol, FSH, LH), inflammatory biomarkers (serum TNFα, IL-6, IL-12, CRP and urine CTX-II), urine AI metabolites, and 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
PATIENT CHARACTERISTICS:
Patients must be postmenopausal, as defined by at least one of the following:
- ≥ 12 months since the last menstrual period
- Prior bilateral oophorectomy
- Current use of a gonadotropin-releasing hormone (GnRH) agonist
- Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (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 have a Zubrod performance status of 0 to 1
- Patients must not have a severe bleeding disorder
- 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 disease affecting the study joint (knees/hands), a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson 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 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Patients must not have had prior acupuncture treatment within the past 12 months or for AI-induced joint symptoms at any time
- Patients must not be on narcotics within 14 days of registration
- Patients must not have received oral corticosteroids, intramuscular corticosteroids, or intra-articular steroids within 28 days prior to registration
- Patients must not have received topical analgesics (e.g., capsaicin preparations) or any other analgesics (e.g., opiates or tramadol, with the exception of nonsteroidal anti-inflammatory drugs [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
Sites / Locations
- Kaiser Permanente-Deer Valley Medical Center
- Kaiser Permanente, Fremont
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente-Oakland
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Saint Luke's Mountain States Tumor Institute
- Saint Luke's Mountain States Tumor Institute - Meridian
- Lahey Hospital and Medical Center
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Grand Rapids Clinical Oncology Program
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Mercy Health Mercy Campus
- Spectrum Health Reed City Hospital
- Munson Medical Center
- Columbia University Medical Center
- Legacy Mount Hood Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Legacy Meridian Park Hospital
- Greenville Health System Cancer Institute-Andrews
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Greenville Health System Cancer Institute-Seneca
- Greenville Health System Cancer Institute-Spartanburg
- Huntsman Cancer Institute/University of Utah
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Seattle Cancer Care Alliance
- Legacy Salmon Creek Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Sham Comparator
No Intervention
Arm I
Arm II
Arm III
Patients receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
Patients receive sham acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.
Patients are assigned to a waiting list for 12 weeks with standard follow-up care.