Lipid Mediators & Cancer: Montelukast, SPM, and Almonds
NCT ID: NCT06887673
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
56 participants
INTERVENTIONAL
2025-03-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm 1 (Control)
ARM 1: Participants in this arm will receive no study treatment other than the standard of care management for their cancer.
No Interventions
No study treatment other than the standard of care management.
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.
Sports Pro Resolve 4 g
Sports Pro Resolve 4 tabs (2 g) twice daily
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.
Double Wood SPM 4 g
Double Wood SPM 4 tabs (2 g) twice daily
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.
20 California Sweet Almonds
10 California Sweet Almonds twice daily
Arm 4: Montelukast 10 mg
ARM 4: Participants in this arm will receive Montelukast 10 mg orally daily for 2 weeks before surgery.
Montelukast 10 Mg Oral Tablet
Montelukast 10 Mg Oral Tablet daily
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.
Montelukast 10 Mg Oral Tablet and SPM 4 g
Montelukast 10 Mg Oral Tablet and SPM 4 g
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
Cold- Pressed Almond Oil 30 mL
Cold- Pressed Almond Oil 30 mL every morning
Interventions
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No Interventions
No study treatment other than the standard of care management.
Sports Pro Resolve 4 g
Sports Pro Resolve 4 tabs (2 g) twice daily
Double Wood SPM 4 g
Double Wood SPM 4 tabs (2 g) twice daily
20 California Sweet Almonds
10 California Sweet Almonds twice daily
Montelukast 10 Mg Oral Tablet
Montelukast 10 Mg Oral Tablet daily
Montelukast 10 Mg Oral Tablet and SPM 4 g
Montelukast 10 Mg Oral Tablet and SPM 4 g
Cold- Pressed Almond Oil 30 mL
Cold- Pressed Almond Oil 30 mL every morning
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Jorge Marcet
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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Tampa General Hospital
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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STUDY006089
Identifier Type: -
Identifier Source: org_study_id
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