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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

120

Study ID:

NCT02831582

Recruitment Status:

Recruiting

Sponsor:

Ohio State University Comprehensive Cancer Center

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There are 3 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Lisa Yee, MD
Contact
626-359-8111
[email protected]
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland Ohio, 44195, United States More Info
Alberto J. Montero, MD
Contact
216-445-1400
[email protected]
Alberto J. Montero, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Maryam Lustberg, MD
Contact
614-293-8858
[email protected]
Maryam Lustberg, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

120

Study ID:

NCT02831582

Recruitment Status:

Recruiting

Sponsor:


Ohio State University Comprehensive Cancer Center

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