Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study

Status: Completed
Location: See location...
Intervention Type: Dietary supplement, Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 supplement may lessen or prevent joint stiffness or pain in patients receiving hormone therapy for breast cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Ohio State University Medical Center
Columbus
Time Frame
Start Date: 2011-10-04
Completion Date: 2014-01-09
Participants
Target number of participants: 44
Treatments
Experimental: Arm I (omega-3 fatty acid supplement)
Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)
Placebo_comparator: Arm II (placebo)
Typical American Diet oils (TAD)
Experimental: Clinical Assessments
Brief Pain Inventory (BPI), Stanford's Health Assessment-Disability Index (HAS), FACT-B and endocrine subscale (FACT-ES)
Experimental: Assessment of therapy complications
Adverse events will be monitored by self-reporting of signs and symptoms. Patients will maintain a daily diary of time of supplement intake and any possible ill effects, with instructions to contact the PI or Research Nurse to discuss and manage any possible side effects.
Experimental: Magnetic Resonance Imaging
Optional bilateral hand and wrist MRI imaging will be obtained
Experimental: Correlative/special studies
Enrolled participants will have peripheral blood samples drawn for plasma and RBC n-3 PUFA levels within 4 weeks of starting AI therapy.
Authors
Maryam Lustberg
Related Therapeutic Areas
Breast Cancer
Sponsors
Leads: Ohio State University Comprehensive Cancer Center
Collaborators: Cancer and Leukemia Group B

This content was sourced from clinicaltrials.gov

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