Status:
COMPLETED
Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Cancer and Leukemia Group B
Conditions:
Recurrent Breast Cancer
Stage IA Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole. Omega-3 fatty acid suppl...
Detailed Description
OBJECTIVES: I. To assess the feasibility of evaluating joint symptoms in postmenopausal women with breast cancer randomized to n-3 PUFA (omega-3 fatty acid) vs. placebo supplementation using the Func...
Eligibility Criteria
Inclusion
- Women diagnosed with breast cancer stages I-III initiating first adjuvant AI therapy with any of the Food and Drug Administration- (FDA) approved AIs (anastrozole, 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
- History of osteoarthritis and/or fibromyalgia is allowed
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Metastatic malignancy of any kind
- Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease, with the exception of osteoarthritis and fibromyalgia
- AI use \> 2 weeks prior to study enrollment
- Known bleeding disorders
- History of diabetes mellitus, heart disease or TIA/stroke
- 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 regular or any other supplements that might interact with n-3 PUFA supplements within six months of study initiation; sporadic use of n-3 PUFA supplement may be eligible if there has been a 3-month washout period prior to randomization
- Pregnant or nursing women
- Known sensitivity or allergy to fish or fish oil
- Concurrent use of daily full dose aspirin (≥ 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products or steroids; one month washout period is required prior to randomization
- Unable to give informed consent
- In patients consenting for optional MRIs, any contraindication to MRI examination including but not limited to ferromagnetic metal in the body, pacemaker, or severe claustrophobia
Key Trial Info
Start Date :
October 4 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01478477
Start Date
October 4 2011
End Date
January 9 2014
Last Update
February 27 2023
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210