Clinical Trial

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

Not Yet Recruiting Early Phase 1
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Record status
This record was last updated March 20, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06887673
Lead Sponsor University of South Florida
Conditions Colorectal Cancer, Sarcoma, Brain Tumors, Endometrial Cancer, Ovarian Cancer
Enrollment 56 participants
Start Date 2025-03
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-03-20