Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT06887673
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Mar 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Arm 1 (Control)
    ARM 1: Participants in this arm will receive no study treatment other than the standard of care management for their cancer.
  • Experimental: Arm 2A: Sports Pro Resolve 4 g
    ARM 2A: Participants in this arm will receive 4 tabs (2 g) in the morning and 4 tabs (2 g) in the evening for 2 weeks before surgery.
  • Experimental: Arm 2B: Double Wood SPM 4 g
    ARM 2B: Participants in this arm will receive 4 tabs (2 g) in the morning and 4 tabs (2 g) in the evening for 2 weeks before surgery.
  • Experimental: Arm 3: California Sweet Almonds- 20 (Skin-on, Unsalted and Unprocessed)
    ARM 3: Participants in this arm will receive 20 skin-on, unsalted, unprocessed California Sweet Almonds, consumed as 10 almonds twice per day, for 2 weeks prior to surgery.
  • Experimental: Arm 4: Montelukast 10 mg
    ARM 4: Participants in this arm will receive Montelukast 10 mg orally daily for 2 weeks before surgery.
  • Experimental: Arm 5: Montelukast 10 mg and SPM supplement 4 g
    ARM 5: Participants in this arm will receive a combination of Montelukast 10 mg daily and the determined SPM supplement 4 g daily, depending on which supplement produce the most SPMs in plasma.
  • Experimental: Arm 6: Cold-Pressed Almond Oil 30 milliliter
    ARM 6; Participants in this arm will receive 30 milliliter of cold-pressed almond oil every morning with breakfast for 2 weeks before surgery

Primary Outcome Measure

Quantity of lipid mediators in a tumor specimen after 2 weeks of study treatment. [ Time Frame: Day 14 of treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606
Avennette Pinto
[email protected]
813-505-4787
Beth Montera
[email protected]
Jorge Marcet, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606
Avennette Pinto
[email protected]
813-505-4787
Beth Montera
[email protected]
Jorge Marcet, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Tampa General Hospital· Tampa, FLUniversity of South Florida· Tampa, FL

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