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Altering Lipids for Tolerance of Aromatase Inhibitor Therapy

NCT04268134 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2026-05-06

Study results available
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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

Interventions

DIETARY_SUPPLEMENT

Omega-3 fatty acid supplement

4 capsules taken by mouth each day for 24 weeks (starting at the week 12 visit).

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Lynn Henry, MD, PhD · University of Michigan Rogel Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-28
Primary Completion
2024-02-27
Completion
2024-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04268134 on ClinicalTrials.gov