RightFit
Not yet recruitingEarly Phase 1

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests montelukast, almonds or almond oil, and SPMs—substances that help the body stop inflammation. It looks at changes in fats and immune cells, including immune cells near tumors. It is for adults with certain newly diagnosed cancers who are planning surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have newly diagnosed stage I–IV colorectal or ovarian cancer, grade 1 or 2 endometrial cancer, a brain tumor, or sarcoma.
  • Have surgery planned at least 2 weeks after joining.
  • Understand the study and agree to sign consent forms for this study and the USF/Tampa General Hospital study that stores samples.
  • Be age 18 or older.

Who can't join

  • Cannot understand and consent to the study because of a mental condition; are unlikely to follow study rules; or are a prisoner.
  • Have allergies to fish, seafood, aspirin, NSAIDs (pain medicines such as ibuprofen), montelukast, or nuts; cannot swallow pills or chew almonds.
  • Have a history of asthma, COPD (long-term lung disease), PKU (a condition that affects how the body breaks down part of protein), mental illness, or an organ transplant.
  • Have uncontrolled high blood pressure or diabetes; long-term liver disease, liver scarring, poor liver function, or certain liver tests over twice the normal limit; or an ongoing serious infection.
  • Have a bleeding disorder, poor bone marrow function, or low red blood cells, white blood cells, or platelets confirmed by repeat tests; take blood thinners or long-term medicines that weaken the immune system.
  • Have surgery planned more than 8 weeks after joining or need emergency surgery; have no clear mass on a scope exam or scan; have another cancer at the same time; or have already started cancer treatment meant to come before surgery.
  • Are pregnant, breastfeeding, or planning pregnancy during the study; or could become pregnant but do not use effective birth control or cannot or will not take pregnancy tests.
  • Used leukotriene-blocking medicines, omega-3 supplements, or almonds in the past 4 weeks; used an experimental drug in the past 6 months; or, after joining, use products assigned to another study group.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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. 2. Participants scheduled for surgical intervention at least two (2) weeks from the day of enrollment. 3. 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). 4. Age 18 or older. Exclusion Criteria: 1. Inability to give consent due to a mental condition that makes the participant unable to understand the study's nature, scope, and possible consequences. 2. Participants who are unlikely to adhere to the protocol as determined by the study investigator. 3. Allergy to fish, seafood, aspirin, NSAIDs, montelukast, or nuts 4. Participants with a history of asthma or chronic obstructive pulmonary disease (COPD). 5. Patients with a history of phenylketonuria (PKU). 6. Participants with a history of a psychiatric illness (e.g., major depression, anxiety disorder, bipolar disorder, obsessive-compulsive disorder, etc.). 7. Surgical intervention scheduled more than eight (8) weeks from the initial enrollment day. 8. No evidence of a discrete mass on endoscopy or radiologic imaging 9. Concomitant existence of other malignancies 10. Uncontrolled hypertension or diabetes mellitus 11. Chronic Liver Disease or cirrhosis 12. 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) 13. 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 14. Use of antiplatelet or anticoagulant medications, including aspirin, clopidogrel, warfarin, direct oral anticoagulants (DOACs), and heparin, among others 15. Persistent significant or severe infection, either acute or chronic 16. Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest): 1. Hematocrit \< 35% and/or 2. Absolute white blood cell count \< 3000 cells/mm3 (μL) and/or 3. Platelet count \< 150 000 cells/mm3 (μL) and/or 4. Absolute neutrophil ≤ 1500 cells/mm3 (μL) 17. Chronic use of immunosuppressive medications 18. History of organ transplantation 19. Emergency surgery 20. Pregnant or breast-feeding women or those who plan to become pregnant during the study. 21. 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. 22. Prisoners 23. Participants who have received treatment with leukotriene inhibitors, taken omega-3 supplements, or eaten almonds within the last 4 weeks. 24. Prior use of any investigational drug in the preceding six (6) months 25. 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) 26. Participants who are unable to swallow oral medication or chew almonds. 27. Participants who have already started neoadjuvant therapies for their cancer diagnosis

Study sites (2)

FL