Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

NCT06887673 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: STUDY006089
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer; Sarcoma; Brain Tumors; Endometrial Cancer; Ovarian Cancer

Keywords

Montelukast; Almonds/Almond oil; Specialized pro-resolving mediators; Tumor-associated macrophages; Lipid mediators; Colorectal cancer; Inflammation

Outcome Measures

Primary Outcomes (2)

• Quantity of lipid mediators in a tumor specimen after 2 weeks of study 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).

  Day 14 of treatment

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

  Day 14 of treatment

Secondary Outcomes (4)

• Quantity of tumor microenvironment subpopulations in a tumor specimen versus corresponding normal tissue after 2 weeks of study treatment.

  Day 14 of treatment

• Distribution of tumor-associated macrophage (TAM) phenotype in tumor specimens versus corresponding normal tissue after 2 weeks of study treatment.

  Day 14 of treatment

• Functionality of tumor-associated macrophages in tumor specimens versus corresponding normal tissue after 2 weeks of study treatment.

  Day 14 of treatment

• Change in quantity of lipids in peripheral blood from day 0 to day 14 of study treatment.

  Day 0 and Day 14

Study Arms (7)

Arm 1 (Control)

OTHER

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

Other: No Interventions

Arm 2A: Sports Pro Resolve 4 g

EXPERIMENTAL

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.

Dietary Supplement: Sports Pro Resolve 4 g

Arm 2B: Double Wood SPM 4 g

EXPERIMENTAL

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.

Dietary Supplement: Double Wood SPM 4 g

Arm 3: California Sweet Almonds- 20 (Skin-on, Unsalted and Unprocessed)

EXPERIMENTAL

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.

Dietary Supplement: 20 California Sweet Almonds

Arm 4: Montelukast 10 mg

EXPERIMENTAL

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

Drug: Montelukast 10 Mg Oral Tablet

Arm 5: Montelukast 10 mg and SPM supplement 4 g

EXPERIMENTAL

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.

Combination Product: Montelukast 10 Mg Oral Tablet and SPM 4 g

Arm 6: Cold-Pressed Almond Oil 30 milliliter

EXPERIMENTAL

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

Dietary Supplement: Cold- Pressed Almond Oil 30 mL

Interventions

No Interventions OTHER

No study treatment other than the standard of care management.

Arm 1 (Control)

Sports Pro Resolve 4 g DIETARY_SUPPLEMENT

Sports Pro Resolve 4 tabs (2 g) twice daily

Arm 2A: Sports Pro Resolve 4 g

Double Wood SPM 4 g DIETARY_SUPPLEMENT

Double Wood SPM 4 tabs (2 g) twice daily

Arm 2B: Double Wood SPM 4 g

20 California Sweet Almonds DIETARY_SUPPLEMENT

10 California Sweet Almonds twice daily

Arm 3: California Sweet Almonds- 20 (Skin-on, Unsalted and Unprocessed)

Montelukast 10 Mg Oral Tablet DRUG

Montelukast 10 Mg Oral Tablet daily

Arm 4: Montelukast 10 mg

Montelukast 10 Mg Oral Tablet and SPM 4 g COMBINATION_PRODUCT

Montelukast 10 Mg Oral Tablet and SPM 4 g

Arm 5: Montelukast 10 mg and SPM supplement 4 g

Cold- Pressed Almond Oil 30 mL DIETARY_SUPPLEMENT

Cold- Pressed Almond Oil 30 mL every morning

Arm 6: Cold-Pressed Almond Oil 30 milliliter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Patients with a history of phenylketonuria (PKU).
• Participants with a history of a psychiatric illness (e.g., major depression, anxiety disorder, bipolar disorder, obsessive-compulsive disorder, etc.).
• Surgical intervention scheduled more than eight (8) weeks from the initial enrollment day.
• No evidence of a discrete mass on endoscopy or radiologic imaging
• Concomitant existence of other malignancies
• Uncontrolled hypertension or diabetes mellitus
• Chronic Liver Disease or cirrhosis
• 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)
• 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
• Use of antiplatelet or anticoagulant medications, including aspirin, clopidogrel, warfarin, direct oral anticoagulants (DOACs), and heparin, among others
• Persistent significant or severe infection, either acute or chronic

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (2)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

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MeSH Terms

Conditions

Colorectal Neoplasms; Sarcoma; Brain Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Inflammation

Interventions

montelukast; Tablets

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jorge Marcet

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avennette Pinto

CONTACT

813-505-4787; apinto3@usf.edu

Beth Montera

CONTACT

bmontera@usf.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 20, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)