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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: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT04268134 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Plasma oxylipins from blood samples collected at the start of O3-FA supplementation (3 months after start of Aromatase Inhibitor \[AI\] therapy alone) and after 3 months of AI therapy + O3-FA supplementation (6 months after start of AI therapy alone) will be quantified using solid phase extraction-liquid chromatography-electrospray ionization tandem mass spectroscopy. Oxylipins will be grouped according to PUFA substrate (linoleic acid \[LA\], arachidonic acid \[AA\], alpha-linoleic acid \[ALA\]
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 |
What the finished NCT04268134 record still lists
NCT04268134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Omega-3 fatty acid supplement is the first listed.
NCT04268134 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04268134's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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