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NCT04268134 · ClinicalTrials.gov registry record · Phase 2
Altering Lipids for Tolerance of Aromatase Inhibitor Therapy
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT04268134 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 77 participants.
The verdict
NCT04268134, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Omega-3 fatty acid supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2024-02-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04268134
The ClinicalTrials.gov registry entry for NCT04268134 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omega-3 fatty acid supplement is the first listed.
NCT04268134 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04268134 about?
NCT04268134 is a clinical study titled "Altering Lipids for Tolerance of Aromatase Inhibitor Therapy". 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, a...
What is the current status of trial NCT04268134?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2020-07-28. Estimated completion is 2024-02-27.
What interventions are being tested in trial NCT04268134?
The interventions under investigation include: Omega-3 fatty acid supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04268134?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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