Status:
NOT_YET_RECRUITING
Lipid Mediators & Cancer: Montelukast, SPM, and Almonds
Lead Sponsor:
University of South Florida
Conditions:
Colorectal Cancer
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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.
- Participants scheduled for surgical intervention at least two (2) weeks from the day of enrollment.
- 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).
- Age 18 or older.
Exclusion
- Inability to give consent due to a mental condition that makes the participant unable to understand the study's nature, scope, and possible consequences.
- Participants who are unlikely to adhere to the protocol as determined by the study investigator.
- Allergy to fish, seafood, aspirin, NSAIDs, montelukast, or nuts
- Participants with a history of asthma or chronic obstructive pulmonary disease (COPD).
- Patients with a history of phenylketonuria (PKU).
- Participants with a history of a psychiatric illness (e.g., major depression, anxiety disorder, bipolar disorder, obsessive-compulsive disorder, etc.).
- Surgical intervention scheduled more than eight (8) weeks from the initial enrollment day.
- No evidence of a discrete mass on endoscopy or radiologic imaging
- Concomitant existence of other malignancies
- Uncontrolled hypertension or diabetes mellitus
- Chronic Liver Disease or cirrhosis
- 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)
- 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
- Use of antiplatelet or anticoagulant medications, including aspirin, clopidogrel, warfarin, direct oral anticoagulants (DOACs), and heparin, among others
- Persistent significant or severe infection, either acute or chronic
- Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest):
- Hematocrit \< 35% and/or
- Absolute white blood cell count \< 3000 cells/mm3 (μL) and/or
- Platelet count \< 150 000 cells/mm3 (μL) and/or
- Absolute neutrophil ≤ 1500 cells/mm3 (μL)
- Chronic use of immunosuppressive medications
- History of organ transplantation
- Emergency surgery
- Pregnant or breast-feeding women or those who plan to become pregnant during the study.
- 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.
- Prisoners
- Participants who have received treatment with leukotriene inhibitors, taken omega-3 supplements, or eaten almonds within the last 4 weeks.
- Prior use of any investigational drug in the preceding six (6) months
- 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)
- Participants who are unable to swallow oral medication or chew almonds.
- Participants who have already started neoadjuvant therapies for their cancer diagnosis
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06887673
Start Date
March 1 2025
End Date
March 1 2026
Last Update
March 20 2025
Active Locations (2)
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1
Tampa General Hospital
Tampa, Florida, United States, 33606
2
University of South Florida
Tampa, Florida, United States, 33606