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SWOG-S1200 A Randomized Blinded Sham- and Waitlist-Controlled Trial of
Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in
Women with Early Stage Breast Cancer
Background:Despite the well-proven efficacy of Aromatase Inhibitors for the treatment of hormone-sensitive breast cancer, some patients suffer from side effects or even stop treatment early due to undesirable toxicities. The most common side effects of AIs are hot flashes, vaginal dryness, musculoskeletal pain and headache, and possibly alterations in serum lipid profiles. In addition, all third-generation AIs increase bone resorption and may predispose to osteoporosis and fractures.Acupuncture is a popular non-pharmacological modality used for treating a variety of conditions, including musculoskeletal pain. Acupuncture has been shown to have short-term analgesic effect in musculoskeletal pain. Clinical trials have found a benefit to patients with knee osteoarthritis when acupuncture is used as an adjunct to conventional management strategies.Approximately 25% of the population over the age of 55 years is affected by joint pain and about half of them will have some restriction of normal daily activities. Virtually all individuals over the age of 65 have radiographic evidence of osteoarthritis. With conventional approaches such as analgesics and exercise, controlling pain and minimizing loss of function are the principal aims of treatment. About two-thirds of individuals who suffer from joint pain have used complementary and alternative treatments to control their symptoms.Objectives: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.Description of Study Arms:Endpoints:Reduction in worst joint pain at 6 weeks between the true acupuncture compared to sham acupuncture and waitlist control groups: A difference of two points in the modified Brief Pain Inventory worst pain score has been identified as a clinically meaningful difference. This item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine.Investigate the effects of true acupuncture compared to sham acupuncture and waitlist control on several measures compared to baseline.Follow-up:Follow-up visits will be scheduled at six weeks, twelve weeks, twenty-four weeks, and fifty-two weeks.Statistics/Analysis:Patients will be stratified at randomization by study site to account for potential site-specific variation in the administration of acupuncture. The primary endpoint of 6 weeks was chosen in order to confirm initial results of a 6-week acupuncture intervention given twice weekly in a larger multicenter study.A multiple linear regression analysis of the primary endpoint will include the baseline score as well as the pre-specified stratification factor. To allow for an ineligibility of 8% (based on a recent study, S0715), a total of 228 patients will be enrolled to achieve 208 eligible patients.The potential for different dropout by arm, especially with respect to the waitlist control, will be mitigated by monthly conferences among study investigators to encourage proper assessment and submission of forms at every required time-point for all patients. Dropout patterns will be monitored on an ongoing basis.
Inclusion and Exclusion Criteria
- 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 TNF
- University of Southern California/Norris Cancer Center, Los Angeles, California, 90033
- Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, 84112
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, 98109
- Munson Medical Center, Traverse City, Michigan, 49684