Lipid Mediators & Cancer: Montelukast, SPM, and Almonds
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- No Interventions
- Sports Pro Resolve 4 g
- Double Wood SPM 4 g
- 20 California Sweet Almonds
- Montelukast 10 Mg Oral Tablet
- Montelukast 10 Mg Oral Tablet and SPM 4 g
- Cold- Pressed Almond Oil 30 mL
Treatment groups
56 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov