Omega-3-Fatty Acid on Joint Symptoms Inducted by Aromatase Inhibitors

Exclusion Criteria

• •Use of omega-3-fatty acid within the past three (3) months
• •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 monarticular arthritis clinically consistent with pseudogout, Paget's disease affecting the study joint, a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson's disease, hemochromatosis, alkaptonuria, or primary osteochondromatosis.
• •History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).
• •History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.
• •History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.
• •Allergy to, or history of significant clinical or laboratory adverse experience associated with omega-3 fatty acid
• •Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.
• •Inability to understand the study procedures and/or give written informed consent.
• •Alcohol use in excess of 3 mixed drinks/day.
• •Corticosteroid treatment as follows:
• •1. Use of oral corticosteroids within the previous four weeks.
• •2. Exposure to intramuscular corticosteroids within one month prior to entering the study.
• •3. Administration of intra-articular steroids to the study joint, within 3 months of Randomization Visit.
• •4. Administration of intra-articular steroids to any other joint, within 3 months of Randomization Visit.
• •Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.
• •Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and acetaminophen) within 2 weeks of Randomization Visit or during the study.
• •Implementation of any other medical therapy for arthritis within one month prior to entry.
• •Other medications, unrelated to the patient's joint pain/stiffness must have been used at a stable dosage for at least 1 month. In addition, it should be anticipated that the dose of the concomitant medication will be stable during the entire treatment period.
• •Participation in another clinical study with an investigational agent within the last 4 weeks.
• •Exposure to omega-3-fatty acid within 3 months of Baseline Visit.