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NCT06887673 | NOT YET RECRUITING | Colorectal Cancer

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds
Sponsor:

University of South Florida

Brief 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.

Condition or disease

Colorectal Cancer

Sarcoma

Brain Tumors

Endometrial Cancer

Ovarian Cancer

Intervention/treatment

No Interventions

Sports Pro Resolve 4 g

Double Wood SPM 4 g

20 California Sweet Almonds

Montelukast 10 Mg Oral Tablet

Montelukast 10 Mg Oral Tablet and SPM 4 g

Cold- Pressed Almond Oil 30 mL

Phase

EARLY_PHASE1

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 56 participants
Masking : NONE
Masking Description : None (Open Label)
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-03
Estimated Primary Completion Date : 2026-03
Estimated Study Completion Date : 2026-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

Location Details

NCT06887673

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How to Participate

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Locations

Not yet recruiting

United States, Florida

Tampa General Hospital

Tampa, Florida, United States, 33606

Not yet recruiting

United States, Florida

University of South Florida

Tampa, Florida, United States, 33606