Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• University of South Florida

  lead OTHER

Principal Investigators

• Jorge Marcet · University of South Florida

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2026-03-31

Completion

2026-03-31

FDA Drug

Yes

Countries

• United States

Study Locations