drugset / Trial / NCT06887673

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

NCT06887673

Phase 0 Not yet recruiting 56 enrolled University of South Florida
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-03
Primary completion
2026-03
Completion
2026-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Montelukast Other / unclassified 10 mg Oral