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Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Study First Submitted
University of South Florida
79 trials monitored
See 2 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Ovarian Cancer
1,336 trials monitored
See 90 trials at risk
Sarcoma
1,026 trials monitored
See 67 trials at risk
and 1 more disease
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
(from sponsor)		 Colorectal Cancer, Sarcoma, Brain Tumors, Endometrial Cancer, Ovarian Cancer
Related terms Brain Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Inflammation, Ovarian Neoplasms, Sarcoma
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov