Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

Launched by UNIVERSITY OF SOUTH FLORIDA · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Lipid Mediators & Cancer: Montelukast, SPM, and Almonds," is designed to explore how certain treatments might affect cancer in patients with colorectal cancer, sarcoma, brain tumors, endometrial cancer, or ovarian cancer. The study will specifically look at the effects of montelukast (a medication), specialized pro-resolving mediators (SPMs), and almonds or almond oil on the body’s fat levels and immune cells that are associated with tumors. Researchers believe that these treatments may help reduce inflammation and improve the immune system's response to cancer.

To be eligible for this trial, participants should be at least 18 years old and newly diagnosed with specific stages of colorectal or ovarian cancer, or certain types of brain tumors and sarcoma. They must also be scheduled for surgery within two weeks after joining the study. Participants can expect to receive either montelukast, SPMs, or almonds/almond oil and will be monitored for changes in their health and immune system. It's important to know that individuals with certain health conditions, allergies, or those who have had recent treatments may not be able to participate.

Gender

ALL

Eligibility 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