Tests montelukast, SPMs, and almonds in people with certain cancers

Trial details

Who runs it

University of South Florida

Trial code

NCT06887673

Record updated

20 March 2025

Original description

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-associated macrophages (TAMs) in cancer patients (colorectal cancer, sarcoma, brain tumors, endometrial cancer, and ovarian cancer). The focus will be on assessing changes in lipid mediator concentrations, TAM reprogramming, and immune cell function in treated versus untreated patients. It is hypothesized that montelukast will reduce the pro-inflammatory effects of leukotriene B4 (LTB4), while SPMs and almonds/almond oil will shift the balance toward pro-resolving mediators, enhancing anti-inflammatory and immune-stimulatory responses and reprogramming TAMs.Read full original descriptionShow less

Exploring the Impact of Montelukast, SPM, and/or Almond/Almond Oil Supplementation on Lipid Mediator Biosynthesis in Colorectal, Sarcomas, Brain Tumors, Endometrial, and Ovarian Cancer: A Pilot Study

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-associated macrophages (TAMs) in cancer patients (colorectal cancer, sarcoma, brain tumors, endometrial cancer, and ovarian cancer). The focus will be on assessing changes in lipid mediator concentrations, TAM reprogramming, and immune cell function in treated versus untreated patients. It is hypothesized that montelukast will reduce the pro-inflammatory effects of leukotriene B4 (LTB4), while SPMs and almonds/almond oil will shift the balance toward pro-resolving mediators, enhancing anti-inflammatory and immune-stimulatory responses and reprogramming TAMs.

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: 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; 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; 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); 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).

ClinicalTrials.gov NCT06887673