Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ohio State University Comprehensive Cancer Center
PRIMARY OBJECTIVES:
I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA) supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs).
SECONDARY OBJECTIVES:
I. To prospectively define the population most at risk for developing AIIAs by the identification and validation of genetic risk predictors and to develop a single nucleotide polymorphism (SNP)/gene profile predictive of treatment intervention response.
OUTLINE: Patients are randomized to 1 of 2 groups.
Group I: Patients receive omega-3 fatty acid supplementation orally (PO) once daily (QD) for 6 months.
Group II: Patients receive placebo PO QD for 6 months.
After completion of study, patients will be followed up periodically.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole, exemestane, letrozole)
Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed.
Prior tamoxifen use is allowed
Prior chemotherapy is allowed
Ability to understand and the willingness to sign a written informed consent document
You may not be if
Metastatic malignancy of any kind
Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease
AI use \> 21 days prior to study enrollment
Known bleeding disorders
Current use of warfarin or other anticoagulants
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if \> 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
