Montelukast + SPMs + Almonds for Cancer

Recruiting at 1 trial location

Overseen By Beth Montera

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of South Florida

Must not be taking: Antiplatelets, Anticoagulants, Immunosuppressives, others

Disqualifiers: Asthma, COPD, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

56 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using antiplatelet or anticoagulant medications, or if you have taken leukotriene inhibitors, omega-3 supplements, or eaten almonds in the last 4 weeks.

What evidence supports the effectiveness of the drug Montelukast in cancer treatment?

Research shows that Montelukast, a drug typically used for asthma, can also help slow down lung cancer growth by causing cancer cells to die. This suggests it might be useful in cancer prevention and treatment. ^{1 2 3 4 5}

Is the combination of Montelukast, SPMs, and Almonds safe for humans?

Montelukast has been linked to some safety concerns, including the risk of Churg-Strauss syndrome (a rare disease causing inflammation of blood vessels) and neuropsychiatric side effects (mental health-related issues) in children. However, these studies focus on Montelukast alone, and there is no specific safety data available for the combination with SPMs and Almonds. ^{6 7 8 9 10}

How does the treatment with Montelukast, SPMs, and Almonds differ from other cancer treatments?

This treatment is unique because it combines Montelukast, a drug known for its use in asthma, with SPMs (specialized pro-resolving mediators) and almonds, which are not standard cancer treatments. Montelukast has shown potential in inducing cancer cell death, making this combination a novel approach to cancer therapy. ^{1 2 5 8 11}

What is the purpose of 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.

Research Team

Jorge Marcet

Principal Investigator

University of South Florida

Eligibility Criteria

This trial is for individuals with certain cancers (colorectal, ovarian, soft tissue sarcoma, brain cancer, endometrial) who are interested in how montelukast, almonds/almond oil, and SPMs might affect their lipid profiles and immune cells. Specific eligibility criteria details were not provided.

Inclusion Criteria

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)

My surgery is scheduled for at least two weeks after I join the study.

I have been newly diagnosed with early or advanced stage colorectal, ovarian cancer, low-grade endometrial cancer, brain tumors, or sarcoma.

Exclusion Criteria

I have not used leukotriene inhibitors, omega-3 supplements, or eaten almonds in the last 4 weeks.

Prior use of any investigational drug in the preceding six months

Participants who are unlikely to adhere to the protocol as determined by the study investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive montelukast, almonds/almond oil, and/or specialized pro-resolving mediators for 2 weeks before surgery

2 weeks

Daily administration

Surgery and Sample Collection

Tissue samples are collected post-surgery for analysis of lipid mediator concentrations and TAM reprogramming

1 day

Follow-up

Participants are monitored for changes in lipid mediator concentrations and immune cell function

4 weeks

Treatment Details

Interventions

• Almonds
• Montelukast
• SPMs

Trial Overview The study investigates the impact of montelukast (a medication), specialized pro-resolving mediators (SPMs), and almonds/almond oil on lipid mediators and tumor-associated macrophages in patients versus those untreated. It aims to see if these interventions can promote anti-inflammatory effects and improve immune function.

Participant Groups

Group I: Arm 6: Cold-Pressed Almond Oil 30 milliliter Experimental Treatment 1 Intervention

ARM 6; Participants in this arm will receive 30 milliliter of cold-pressed almond oil every morning with breakfast for 2 weeks before surgery

Group II: Arm 5: Montelukast 10 mg and SPM supplement 4 g Experimental Treatment 1 Intervention

ARM 5: Participants in this arm will receive a combination of Montelukast 10 mg daily and the determined SPM supplement 4 g daily, depending on which supplement produce the most SPMs in plasma.

Group III: Arm 4: Montelukast 10 mg Experimental Treatment 1 Intervention

ARM 4: Participants in this arm will receive Montelukast 10 mg orally daily for 2 weeks before surgery.

Group IV: Arm 3: California Sweet Almonds- 20 (Skin-on, Unsalted and Unprocessed) Experimental Treatment 1 Intervention

ARM 3: Participants in this arm will receive 20 skin-on, unsalted, unprocessed California Sweet Almonds, consumed as 10 almonds twice per day, for 2 weeks prior to surgery.

Group V: Arm 2B: Double Wood SPM 4 g Experimental Treatment 1 Intervention

ARM 2B: Participants in this arm will receive 4 tabs (2 g) in the morning and 4 tabs (2 g) in the evening for 2 weeks before surgery.

Group VI: Arm 2A: Sports Pro Resolve 4 g Experimental Treatment 1 Intervention

ARM 2A: Participants in this arm will receive 4 tabs (2 g) in the morning and 4 tabs (2 g) in the evening for 2 weeks before surgery.

Group VII: Arm 1 (Control) Experimental Treatment 1 Intervention

ARM 1: Participants in this arm will receive no study treatment other than the standard of care management for their cancer.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Findings from Research

Montelukast is an effective treatment for persistent asthma in patients aged 6 years and older, showing significant improvements in lung function and quality of life within just one day of starting treatment, as demonstrated in multiple clinical trials involving both adults and children.

The drug is well tolerated with a safety profile similar to placebo, and it can reduce the need for inhaled corticosteroids, making it a valuable option for asthma management, either alone or in combination with other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Montelukast: a review of its therapeutic potential in persistent asthma. Jarvis, B., Markham, A.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Montelukast Induces Apoptosis-Inducing Factor-Mediated Cell Death of Lung Cancer Cells. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Montelukast: a review of its therapeutic potential in persistent asthma. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Montelukast, a once-daily leukotriene receptor antagonist, in the treatment of chronic asthma: a multicenter, randomized, double-blind trial. Montelukast Clinical Research Study Group. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Montelukast for prevention and treatment of asthma exacerbations in adults: Systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Metabolic profiles of montelukast sodium (Singulair), a potent cysteinyl leukotriene1 receptor antagonist, in human plasma and bile. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Refractory symptoms successfully treated with leukotriene inhibition in a child with systemic mastocytosis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The leucotriene receptor antagonist montelukast and the risk of Churg-Strauss syndrome: a case-crossover study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment with 400 microg of inhaled budesonide vs 200 microg of inhaled budesonide and oral montelukast in children with moderate persistent asthma: randomized controlled trial. [2021]

9. Poland pubmed.ncbi.nlm.nih.gov

[Churg-Strauss syndrome: diagnostic and therapeutic challenge - a case report]. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Neuropsychiatric adverse drug reactions induced by montelukast impair the quality of life in children with asthma. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on montelukast in asthma in children 2 to 14 years of age. [2021]