Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

Prior treatment

• Surgical intervention scheduled more than eight (8) weeks from the initial enrollment day.
• Concomitant existence of other malignancies
• Use of antiplatelet or anticoagulant medications, including aspirin, clopidogrel, warfarin, direct oral anticoagulants (DOACs), and heparin, among others
• Chronic use of immunosuppressive medications
• Emergency surgery
• 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 are unable to swallow oral medication or chew almonds.

Other illness

• Inability to give consent due to a mental condition that makes the participant unable to understand the study's nature, scope, and possible consequences.
• 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.).
• Uncontrolled hypertension or diabetes mellitus
• Chronic Liver Disease or cirrhosis
• Persistent significant or severe infection, either acute or chronic
• History of organ transplantation
• Participants who have already started neoadjuvant therapies for their cancer diagnosis

Lab values

• 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
• 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)

Other

• Participants who are unlikely to adhere to the protocol as determined by the study investigator.
• No evidence of a discrete mass on endoscopy or radiologic imaging
• 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, 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)

• 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.