Breast Cancer Clinical Trial
Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer
Summary
This clinical trial studies the use of omega-3 fatty acid supplementation in preventing aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3 supplementation may help relieve moderate to severe bone pain and improve joint symptoms caused by aromatase inhibitor-induced arthralgias.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Pregnant or nursing women
Known sensitivity or allergy to fish or fish oil
Unable to give informed consent
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There are 3 Locations for this study
Cleveland Ohio, 44195, United States More Info
Principal Investigator
Columbus Ohio, 43210, United States More Info
Principal Investigator
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