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NOT YET RECRUITING
NCT06887673
EARLY_PHASE1

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

Sponsor: University of South Florida

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-03

Completion Date

2026-03

Last Updated

2025-03-20

Healthy Volunteers

No

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

Locations (2)

Tampa General Hospital

Tampa, Florida, United States

University of South Florida

Tampa, Florida, United States