Montelukast, SPMs, and Almonds for Colorectal, Sarcoma, Brain, Endometrial, and Ovarian Cancers

This study is looking at how montelukast, specialized pro-resolving mediators (SPMs), and almonds might affect certain types of cancer. Researchers want to see if these interventions can change lipid (fat) levels and immune cells called tumor-associated macrophages (TAMs) in people with colorectal cancer, sarcoma, brain tumors, endometrial cancer, or ovarian cancer. You could be eligible if you are newly diagnosed with one of these cancers, are at least 18 years old, and are scheduled for surgery at least two weeks after enrolling. The study will measure the amount of specific lipid mediators in your tumor and healthy tissue after two weeks of treatment to see if the interventions are having an effect. The study is currently recruiting 56 participants, but its status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 56 participants.
What's involved
You would receive one of the study interventions (Montelukast, Sports Pro Resolve, Double Wood SPM, or California Sweet Almonds) or no intervention for two weeks before your scheduled surgery. Tissue samples will be collected during your surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at Day 14 of treatment, which is when tissue samples are collected after two weeks of study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06887673

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

Not Yet Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of South Florida
~56 participants
Updated 2025-03-20 on ClinicalTrials.gov
What's tested:No InterventionsSports Pro Resolve 4 gDouble Wood SPM 4 g20 California Sweet AlmondsMontelukast 10 Mg Oral TabletMontelukast 10 Mg Oral Tablet and SPM 4 g

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quantity of lipid mediators in a tumor specimen after 2 weeks of study treatment.
Measured over Day 14 of treatment
+1 more outcome measured
Colorectal Cancer
Sarcoma
Brain Tumors
Endometrial Cancer
Ovarian Cancer
2 sites across 1 states
Florida2
  • Jorge Marcet · PRINCIPAL_INVESTIGATOR · University of South Florida

Opens a ready-to-send draft in your own email app — review before sending.

  • Quantity of lipid mediators in a tumor specimen after 2 weeks of study treatment.Day 14 of treatment

    Quantitation will be assessed using liquid chromatography tandem mass spectrometry (LC-MS/MS). The absolute quantity of these lipid mediators will be compared to the absolute quantity in the corresponding normal tissue. In preliminary studies, the investigators have used LC-MS/MS to measure \~65 different lipid mediators of the arachidonic acid pathway in colorectal cancer. Interestingly, the investigators found high proportions of pro-inflammation mediators and depressed levels of pro-resolution-of-inflammation mediators in cancer tissue compared with the non-affected tissue of the same patients. Possible study treatments include: specialized pro-resolving mediators vs Montelukast vs almonds/almond oil vs combination).

  • Quantity of lipid mediators in a non-cancerous (i.e. normal) tissue from the resected surgical specimen after 2 weeks of study treatment.Day 14 of treatment

    Quantitation will be assessed using liquid chromatography tandem mass spectrometry (LC-MS/MS). The absolute quantity of these lipid mediators will be compared to the absolute quantity in the corresponding cancer tissue. This change in quantity will enable us to make deductions about the influence of the corresponding study treatment on the tumor and its environment. For example, does the treatment in question make the tumor environment less inflamed/promote healing and therefore make the cancer more susceptible to treatment? Possible study treatments include: specialized pro-resolving mediators vs Montelukast vs almonds/almond oil vs combination).