Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Locations
- 3
- Primary Endpoint
- Change in pain score based on the Brief Pain Inventory (BPI)
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Arm II (placebo)
Patients receive placebo PO QD for 6 months.
Intervention: Placebo (Other)
Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid supplementation PO QD for 6 months.
Intervention: Omega-3 Fatty Acid (Dietary Supplement)
Outcomes
Primary Outcomes
Change in pain score based on the Brief Pain Inventory (BPI)
Time Frame: Baseline to up to 6 months
Analysis of patterns of change over time in pain scores through the application of hierarchical linear regression models.
Secondary Outcomes
- Change in joint symptoms based on quality of life instruments(Baseline to up to 6 months)
- Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias(Up to 6 months)
- Rate of compliance(Up to 6 months)
- Change in joint symptoms based on symptomatology instruments(Baseline to up to 6 months)
- SNP analysis by standard data preprocessing operations and sequential analysis(Up to 6 months)
Investigators
Nicole Williams
Principal Investigator
Ohio State University Comprehensive Cancer Center