NCT04268134

Altering Lipids for Tolerance of Aromatase Inhibitor Therapy

Omega-3 Fatty Acids, Oxylipins, and Tolerance of Aromatase Inhibitor Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aromatase inhibitor medications have been approved by the U.S Food and Drug Administration (FDA) for treatment of hormone receptor positive breast cancer. This treatment has been shown to be very effective for treating breast cancer. However, some patients have difficulty tolerating the treatment, and some even decide to stop treatment because of the side effects. Research has shown that over half of patients who had joint pain and stiffness when taking an aromatase inhibitor had an improvement in their symptoms when they took omega-3 fatty acid supplements. This study is being conducted to test whether having patients start to take an omega-3 fatty acid supplement soon after they starting taking an aromatase inhibitor medicine will reduce the likelihood that they will have bothersome symptoms.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3 fatty acid supplement	4 capsules taken by mouth each day for 24 weeks (starting at the week 12 visit).

Timeline

• Start date: 2020-07-28
• Primary completion: 2024-02-27
• Completion: 2024-02-27
• First posted: 2020-02-13
• Last updated: 2024-02-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study