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NCT06887673 · ClinicalTrials.gov registry record · Early Phase 1
Lipid Mediators & Cancer: Montelukast, SPM, and Almonds
A Early Phase 1 study, sponsored by University of South Florida.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 56
- Enrollment target
NCT06887673: Clinical Trial Early Phase 1 study, sponsored by University of South Florida.
NCT06887673 is a Early Phase 1 study that has not yet begun recruiting, run by University of South Florida. The registered enrollment target is 56 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06887673, a Early Phase 1 study, has not yet begun recruiting, sponsored by University of South Florida.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this study is to create a prospective investigation to examine the effects of montelukast, almonds/almond oil, and specialized pro-resolving mediators (SPMs) on lipid profiles and tumor-associated macrophages (TAMs) in cancer patients (colorectal cancer, sarcoma, brain tumors, endometrial cancer, and ovarian cancer). The focus will be on assessing changes in lipid mediator concentrations, TAM reprogramming, and immune cell function in treated versus untreated patients. It is hypothesized that montelukast will reduce the pro-inflammatory effects of leukotriene B4 (LTB4), while SPMs and almonds/almond oil will shift the balance toward pro-resolving mediators, enhancing anti-inflammatory and immune-stimulatory responses and reprogramming TAMs.
Primary Outcome
Quantitation will be assessed using liquid chromatography tandem mass spectrometry (LC-MS/MS). The absolute quantity of these lipid mediators will be compared to the absolute quantity in the corresponding normal tissue. In preliminary studies, the investigators have used LC-MS/MS to measure \~65 different lipid mediators of the arachidonic acid pathway in colorectal cancer. Interestingly, the investigators found high proportions of pro-inflammation mediators and depressed levels of pro-resolutio
Interventions
- OTHER No Interventions
- DRUG Montelukast 10 Mg Oral Tablet
- DIETARY_SUPPLEMENT Sports Pro Resolve 4 g
- DIETARY_SUPPLEMENT Double Wood SPM 4 g
- DIETARY_SUPPLEMENT 20 California Sweet Almonds
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2025-03 |
| Est. Completion | 2026-03 |
| Phase | Early Phase 1 |
What is known before NCT06887673 opens enrollment
NCT06887673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which No Interventions is the first listed.
NCT06887673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06887673 about?
NCT06887673 is a clinical study titled "Lipid Mediators & Cancer: Montelukast, SPM, and Almonds". The purpose of this study is to create a prospective investigation to examine the effects of montelukast, almonds/almond oil, and specialized pro-resolving mediators (SPMs) on lipid profiles and tumor-associated macrophages (TAMs) in cancer patients (colorectal cancer, sarcoma, brain tumors, endomet...
What is the current status of trial NCT06887673?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 56 participants. The study started on 2025-03. Estimated completion is 2026-03.
What interventions are being tested in trial NCT06887673?
The interventions under investigation include: No Interventions (OTHER), Montelukast 10 Mg Oral Tablet (DRUG), Sports Pro Resolve 4 g (DIETARY_SUPPLEMENT), Double Wood SPM 4 g (DIETARY_SUPPLEMENT), 20 California Sweet Almonds (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06887673?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06887673's enrollment target sits among peer trials
56 451st of 2000 higher than 1,543 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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