Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT01535066
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01535066
Study Brief:
Protocol Section:
NCT01535066