Montelukast + SPMs + Almonds for Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJorge Marcet

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of South Florida

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jorge Marcet

Principal Investigator

University of South Florida

Eligibility Criteria

This trial is for individuals with certain cancers (colorectal, ovarian, soft tissue sarcoma, brain cancer, endometrial) who are interested in how montelukast, almonds/almond oil, and SPMs might affect their lipid profiles and immune cells. Specific eligibility criteria details were not provided.

Inclusion Criteria

Patients must be able to understand and willing to sign a written informed consent document for both this study and the University of South Florida (USF)/ Tampa General Hospital (TGH) Biorepository study (STUDY000356)

I am 18 years old or older.

My surgery is scheduled for at least two weeks after I join the study.

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Exclusion Criteria

I have not used leukotriene inhibitors, omega-3 supplements, or eaten almonds in the last 4 weeks.

Prior use of any investigational drug in the preceding six months

Participants who are unlikely to adhere to the protocol as determined by the study investigator

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Treatment Details

Interventions

Almonds (Nutritional Supplement)
Montelukast (Leukotriene Receptor Antagonist)
SPMs (Specialized Pro-resolving Mediators)

Trial OverviewThe study investigates the impact of montelukast (a medication), specialized pro-resolving mediators (SPMs), and almonds/almond oil on lipid mediators and tumor-associated macrophages in patients versus those untreated. It aims to see if these interventions can promote anti-inflammatory effects and improve immune function.

Participant Groups

7Treatment groups

Experimental Treatment

Group I: Arm 6: Cold-Pressed Almond Oil 30 milliliterExperimental Treatment1 Intervention

ARM 6; Participants in this arm will receive 30 milliliter of cold-pressed almond oil every morning with breakfast for 2 weeks before surgery

Group II: Arm 5: Montelukast 10 mg and SPM supplement 4 gExperimental Treatment1 Intervention

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.

Group III: Arm 4: Montelukast 10 mgExperimental Treatment1 Intervention

ARM 4: Participants in this arm will receive Montelukast 10 mg orally daily for 2 weeks before surgery.

Group IV: Arm 3: California Sweet Almonds- 20 (Skin-on, Unsalted and Unprocessed)Experimental Treatment1 Intervention

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.

Group V: Arm 2B: Double Wood SPM 4 gExperimental Treatment1 Intervention

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.

Group VI: Arm 2A: Sports Pro Resolve 4 gExperimental Treatment1 Intervention

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.

Group VII: Arm 1 (Control)Experimental Treatment1 Intervention

ARM 1: Participants in this arm will receive no study treatment other than the standard of care management for their cancer.