Clinical Trial Finder

Inclusion Criteria:

1. Newly diagnosed individuals with stages I-IV colorectal or ovarian cancer, grade 1 and 2 endometrial cancer, as well as those with brain tumors or sarcoma. 2. Participants scheduled for surgical intervention at least two

• (2) weeks from the day of enrollment.

3. 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). 4. Age 18 or older.

Exclusion Criteria:

1. Inability to give consent due to a mental condition that makes the participant unable to understand the study's nature, scope, and possible consequences. 2. Participants who are unlikely to adhere to the protocol as determined by the study investigator. 3. Allergy to fish, seafood, aspirin, NSAIDs, montelukast, or nuts. 4. Participants with a history of asthma or chronic obstructive pulmonary disease (COPD). 5. Patients with a history of phenylketonuria (PKU). 6. Participants with a history of a psychiatric illness (e.g., major depression, anxiety disorder, bipolar disorder, obsessive-compulsive disorder, etc.). 7. Surgical intervention scheduled more than eight

• (8) weeks from the initial enrollment day.

8. No evidence of a discrete mass on endoscopy or radiologic imaging. 9. Concomitant existence of other malignancies. 10. Uncontrolled hypertension or diabetes mellitus. 11. Chronic Liver Disease or cirrhosis. 12. Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2x the upper limit of the normal range (ULN) 13. Bleeding conditions such as disorders of platelet function, idiopathic thrombocytopenia purpura (ITP), thrombotic thrombocytopenic purpura (TTP), hemophilia or any clotting factor deficiency, von Willebrand disease or Glanzmann disease among other. 14. Use of antiplatelet or anticoagulant medications, including aspirin, clopidogrel, warfarin, direct oral anticoagulants (DOACs), and heparin, among others. 15. Persistent significant or severe infection, either acute or chronic. 16. Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest): 1. Hematocrit < 35% and/or. 2. Absolute white blood cell count < 3000 cells/mm3 (μL) and/or. 3. Platelet count < 150 000 cells/mm3 (μL) and/or. 4. Absolute neutrophil ≤ 1500 cells/mm3 (μL) 17. Chronic use of immunosuppressive medications. 18. History of organ transplantation. 19. Emergency surgery. 20. Pregnant or breast-feeding women or those who plan to become pregnant during the study. 21. Women of childbearing potential who are not protected by effective contraceptive methods of birth control and/or are unwilling or unable to be tested for pregnancy. 22. Prisoners. 23. Participants who have received treatment with leukotriene inhibitors, taken omega-3 supplements, or eaten almonds within the last 4 weeks. 24. Prior use of any investigational drug in the preceding six

• (6) months.

25. Participants who, after being enrolled in this study and assigned a particular study treatment, consume products involved in other study cohorts other than what they were assigned (i.e. if a patient is assigned to take SPMs as their study treatment but during the course of the study also is consuming daily almonds) 26. Participants who are unable to swallow oral medication or chew almonds. 27. Participants who have already started neoadjuvant therapies for their cancer diagnosis

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.

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

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