NCT06887673

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

Exploring the Impact of Montelukast, SPM, and/or Almond/Almond Oil Supplementation on Lipid Mediator Biosynthesis in Colorectal, Sarcomas, Brain Tumors, Endometrial, and Ovarian Cancer: A Pilot Study

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective study investigates the effects of montelukast, almonds/almond oil, and specialized pro-resolving mediators (SPMs) on lipid profiles and tumor-associated macrophages (TAMs) in patients with colorectal cancer (CRC), sarcoma, brain tumors (BT), endometrial cancer (EC), and ovarian cancer (OvCa). Patients receiving these treatments will be compared to untreated controls, with tissue samples collected post-surgery for analysis. A cohort of patients who have undergone tumor resection will be included for the assessment of lipid mediator concentrations (approximately 65 arachidonic acid pathway lipids) and TAM reprogramming, with an emphasis on comparing treated and untreated groups. The study will also examine peripheral blood mononuclear cells (PBMCs) and plasma concentrations of lipid mediators before and after treatment, focusing on changes in PBMC function and phenotype. It is hypothesized that montelukast, an LTB4/ cysteinyl leukotriene receptor 1 (CYSLTR1) inhibitor, will reduce the pro-inflammatory effects of LTB4 in cancer tissues. Furthermore, it is anticipated that SPMs and almonds/almond oil will shift the lipid mediator balance toward pro-resolving mediators, enhancing anti-inflammatory responses, stimulating immune function, and reprogramming TAMs.

Conditions

• Colorectal Cancer
• Sarcoma
• Brain Tumors
• Endometrial Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
OTHER	No Interventions	No study treatment other than the standard of care management.
DIETARY_SUPPLEMENT	Sports Pro Resolve 4 g	Sports Pro Resolve 4 tabs (2 g) twice daily
DIETARY_SUPPLEMENT	Double Wood SPM 4 g	Double Wood SPM 4 tabs (2 g) twice daily
DIETARY_SUPPLEMENT	20 California Sweet Almonds	10 California Sweet Almonds twice daily
DRUG	Montelukast 10 Mg Oral Tablet	Montelukast 10 Mg Oral Tablet daily
COMBINATION_PRODUCT	Montelukast 10 Mg Oral Tablet and SPM 4 g	Montelukast 10 Mg Oral Tablet and SPM 4 g
DIETARY_SUPPLEMENT	Cold- Pressed Almond Oil 30 mL	Cold- Pressed Almond Oil 30 mL every morning

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study