Lipid Mediators & Cancer: Montelukast, SPM, and Almonds
Launched by UNIVERSITY OF SOUTH FLORIDA · Mar 14, 2025
Trial Information
Current as of April 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
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 arachidoni...
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
Trial Officials
Jorge Marcet
Principal Investigator
University of South Florida
About University Of South Florida
The University of South Florida (USF) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong commitment to improving patient outcomes, USF leverages its diverse faculty expertise and state-of-the-art facilities to conduct rigorous and ethically sound research. The university fosters collaboration across disciplines, engaging in partnerships that enhance the translation of scientific discoveries into effective therapeutic interventions. USF's clinical trial programs are designed to address pressing health challenges and contribute to the body of knowledge in various medical fields, ultimately aiming to benefit communities and improve public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Tampa, Florida, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported