Montelukast + SPMs + Almonds for Cancer

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether montelukast, almonds, and specialized pro-resolving mediators (SPMs) can enhance the body's response to cancer by reducing inflammation and boosting the immune system. Researchers focus on patients with colorectal cancer, sarcoma, brain tumors, endometrial cancer, and ovarian cancer. Participants will receive different treatments, such as almond oil or montelukast, to determine which is most effective. Individuals newly diagnosed with these cancers and scheduled for surgery might be suitable candidates. As an Early Phase 1 trial, this research explores how these treatments work in people, offering participants a chance to contribute to groundbreaking cancer research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that montelukast is usually well-tolerated. Some studies suggest it might help prevent cancer cells from spreading, particularly in lung cancer. However, the FDA has warned that montelukast could cause serious mental health issues in some individuals.

Research considers almonds and almond oil safe. They are commonly used in foods and cosmetics without causing problems. No evidence links them to cancer or other serious health issues.

Specialized pro-resolving mediators (SPMs) are newer supplements derived from fish oil, intended to help manage inflammation. Products like Sports ProResolve have undergone quality and safety testing and are generally considered safe to use.

Since this trial is in its early stages, the main goal is to determine if these treatments are safe for humans. Detailed safety information might still be limited. Participants should be aware of the potential risks, especially with montelukast. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore unique combinations and natural sources to combat cancer. Unlike standard chemotherapy and targeted therapies, this trial investigates Montelukast, typically used for asthma, combined with specialized pro-resolving mediators (SPMs) and almonds. Montelukast's potential to modulate immune response, SPMs' role in inflammation resolution, and the natural anti-oxidative properties of almonds offer a fresh, multi-faceted approach to cancer treatment. These treatments could potentially enhance the body's own healing processes and provide a less aggressive alternative to current options.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that montelukast, which participants in this trial may receive, can inhibit cancer cell growth by blocking certain pathways they use for movement and survival. Studies have found that it can shrink tumors in lung and colorectal cancer. Participants in this trial may also receive SPMs, substances found in fish oil that may help reduce inflammation linked to cancer growth. Almond oil, another treatment option in this trial, has been found to slow the formation of new blood vessels that tumors need to grow. Together, these treatments might help the body fight cancer by reducing inflammation and cutting off the resources tumors require. ^{6 7 8 9 10}

Who Is on the Research Team?

Jorge Marcet

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9375604/

Antiangiogenic Activity of Sweet Almond (Prunus dulcis) Oil ... Conclusion: Almond oil dose has inhibition effect on cancer and can be used as (anti-angiogenesis), the activity of almond oil with Aspirin synergism can ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06887673

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds The purpose of this study is to create a prospective investigation to examine the effects of montelukast, almonds/almond oil, and specialized pro-resolving ...

3. researchgate.net researchgate.net/publication/360280391_Antiangiogenic_Activity_of_Sweet_Almond_Prunus_dulcis_Oil_Alone_and_in_Combination_with_Aspirin_in_both_in_vivo_and_in_vitro_Assays

Antiangiogenic Activity of Sweet Almond (Prunus dulcis) Oil ... The findings suggest that the activity of sweet almond oil with aspirin synergism can greatly lower blood vessel growth in rat aorta rings and CAM assays.

4. withpower.com withpower.com/trial/early-phase-1-colorectal-neoplasms-2-2025-fc978

Montelukast + SPMs + Almonds for Cancer The purpose of this study is to create a prospective investigation to examine the effects of montelukast, almonds/almond oil, and specialized pro-resolving ...

5. imrpress.com imrpress.com/journal/IJP/20/3/10.3923/ijp.2024.403.425/pdf

Assessment of Sesame and Sweet Almond Oils Efficacy ... Production and evaluation of sweet almond and sesame oil nanoemulsion and their effects on physico-chemical, rheological and microbial characteristics of.

6. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Oils%2C%20almond

Sweet Almond Oil - PubChem - NIH Sigma-Aldrich Corp; Safety Data Sheet for Almond oil, from Prunus dulcis ... To assess the effect of almonds on colon cancer, whole almond-, almond ...

7. freshskin.co.uk freshskin.co.uk/wp-content/uploads/2015/01/sweet-almond-cp-SDS.pdf

Material Safety Data Sheet SWEET ALMOND OIL COLD ... Sweet almond oil is not classified as hazardous, obtained from almond kernels, used in cosmetics, and is not irritant. Store in a cool, dry place, away from ...

8. medline.com medline.com/media/catalog/Docs/MSDS/MSD_SDSD17310.pdf

LORANN OILS, INC. 2020 – Sweet Almond Oil, Natural Refer to special instructions/safety data sheet. If swallowed, do not induce vomiting: seek medical advice immediately and show this ...

9. lotioncrafter.com lotioncrafter.com/products/sweet-almond-oil-virgin-unrefined?srsltid=AfmBOopcdooi3eLDtxilE1ggqXpjqAcemsx-fY8t6PfZ9n4bnknEhrNc

Sweet Almond Oil, Virgin, Unrefined This product is not known to the State of California to cause cancer, birth defects or other reproductive harm. Additionally, exposure to a naturally occurring ...

10. cir-safety.org cir-safety.org/sites/default/files/RR_Sweet%20Almond.pdf

Safety Assessment of Prunus Amygdalus Dulcis (Sweet ... The panel concluded that sweet almond seed meal is safe for topical application to humans in current practices and concentrations.