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A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness In Women With Early Stage Breast Cancer, Phase III




A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness In Women With Early Stage Breast Cancer, Phase III (IRB 012-090)

Study Description:

PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III breast cancer receiving hormone therapy.

Inclusion Criteria:

» DISEASE CHARACTERISTICS:
» Histologically confirmed primary invasive adenocarcinoma of the breast: Stage I, II, or IIIA disease; No metastatic disease
» Must have undergone modified radical mastectomy or breast-sparing surgery and recovered
» Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+)
» Currently taking a third-generation aromatase inhibitor (AI) [e.g., anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)] for ≥ 90 days prior to registration with plans to continue for ≥ 180 days after registration
» Must have completed the S092 Brief Pain Inventory (BPI)-Short Form within the past 14 days, and must have a worst pain/stiffness of ≥ 5 on the BPI (item #2) that has started or increased with AI therapy
» PATIENT CHARACTERISTICS:
» Postmenopausal
» Zubrod performance status 0-2
» Willing to submit blood for serum-free estradiol, total estradiol, serum inflammatory markers (IL6, TNF-α, CRP), DHA and EPA, lipid profile (LDL, HDL, triglycerides), and DNA analysis (CYP19A1)
» Able to complete study questionnaires in English
» At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission
» PRIOR CONCURRENT THERAPY:
» See Disease Characteristics
» At least 3 months since prior omega-3 fatty acid supplements and must agree to refrain from omega-3-fatty acid supplements from sources outside of this study
» More than 28 days since prior investigational agents
» No other medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days
» Patients must not be on anticoagulation medication (i.e., heparin/warfarin) because of increased risk of bleeding within 28 days prior to registration
» 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 be on narcotics within 14 days of registration
» Patients may have received corticosteroid treatment; however, the following criteria apply: Patients must not have received oral or intramuscular corticosteroids within the 28 days prior to registration; Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration
» Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with the exception of NSAIDs and acetaminophen) within 14 days prior to registration

Exclusion Criteria:

» SEE INCLUSION CRITERIA

Location:


Irving Cancer Center
1901 N. MacArthur Blvd.
Irving , TX 75061

Lead Principal Investigator:

Sridevi Juvvadi, MD



This trial is no longer available to enrollment.

Last update: July 10, 2012