Omega-3 fatty acid + Celecoxib for Breast Cancer

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Colorado, Denver

Must not be taking: Immunomodulatory drugs, NSAIDs

Disqualifiers: Autoimmune, Stroke, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

42 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but if you are taking more than one 1000mg fish oil capsule daily or celecoxib, you must stop at least 1 week before starting the study. If you are randomized to the control group, you must abstain from fish oil or celecoxib during the study.

What data supports the effectiveness of the drug combination of Omega-3 fatty acid and Celecoxib for breast cancer?

Research suggests that combining Celecoxib, a drug that can help prevent cancer growth, with Omega-3 fatty acids (found in fish oil) may be more effective in preventing breast cancer than using either one alone. This combination has shown promising results in animal studies, reducing cancer markers and improving tissue health. ^{1 2 3 4 5}

Is the combination of Omega-3 fatty acids and Celecoxib safe for humans?

Celecoxib has been studied in various cancer treatments and is generally well tolerated, with no severe toxicity reported in some trials. Omega-3 fatty acids are known for their protective effects against certain cancers and are considered safe as dietary supplements. ^{1 2 6 7 8}

How does the drug combination of Omega-3 fatty acids and Celecoxib differ from other breast cancer treatments?

The combination of Omega-3 fatty acids and Celecoxib is unique because it targets cancer prevention by reducing inflammation and promoting cancer cell death through a synergistic effect, which is more effective than using either component alone. This approach leverages the anti-inflammatory properties of both components, potentially offering a safer alternative to high doses of Celecoxib, which can have side effects. ^{4 5 8 9 10}

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC). Short-term intervention with anti-inflammatory medications will demonstrate a reduction in the inflammation and immune suppressive phenotype of PABC, and decreased metastatic potential in PABC. This unique window in breast cancer management serves as a valuable opportunity to obtain preliminary data on biomarkers and the alterations that occur when the system is troubled by a drug or other intervention which will be instrumental in designing future therapeutic or preventative strategies for larger clinical study.

Research Team

Virginia Borges, MD, MSc

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for breast cancer patients with normal organ function, an ECOG performance status of 0-1, and a platelet count within the normal range. They must be willing to avoid fish oil or celecoxib if assigned to the control group and agree to surgery at least one week after diagnosis. Exclusions include history of stroke or heart disease, current high-dose fish oil or celecoxib use unless they stop prior to the study, pregnancy intending to continue, autoimmune conditions, chronic steroid use, psychiatric issues affecting compliance, previous cancers except breast cancer treated over 5 years ago.

Inclusion Criteria

Aspartate aminotransferase (AST) =< 2 x ULN

Alanine aminotransferase (ALT) =< 2 x ULN

Alkaline phosphatase =< 2 x ULN

Exclusion Criteria

Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements

I am allergic to fish, NSAIDs, ASA, or COX 2 inhibitors.

I have been diagnosed with breast cancer before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either omega-3 fatty acid or celecoxib until the morning of surgery

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Celecoxib
• Omega-3 fatty acid

Trial Overview The study tests whether short-term treatment with anti-inflammatory drugs (fish oil capsules and COX-2 inhibitor celecoxib) can reduce inflammation and immune suppression in pregnancy-associated breast cancer (PABC), potentially decreasing its ability to spread. The goal is also to gather data on biomarkers affected by these interventions.

Participant Groups

Group I: Arm III (celecoxib) Experimental Treatment 1 Intervention

Patients receive celecoxib by mouth twice a day until the morning of surgery.

Group II: Arm II (fish oil) Experimental Treatment 1 Intervention

Patients receive omega-3 fatty acid by mouth everyday until the morning of surgery.

Group III: Arm I Active Control 1 Intervention

Patients undergo observation.

Celecoxib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Celebrex for:

• Pain relief
• Inflammation
• Osteoarthritis
• Rheumatoid arthritis
• Menstrual cramps
• Colorectal polyps prevention

Approved in European Union as Celebrex for:

• Symptomatic relief in osteoarthritis
• Symptomatic relief in rheumatoid arthritis
• Ankylosing spondylitis
• Acute pain
• Primary dysmenorrhea
• Adenomatous polyposis coli

Approved in Canada as Celebrex for:

• Symptomatic relief of osteoarthritis
• Symptomatic relief of rheumatoid arthritis
• Ankylosing spondylitis
• Acute pain
• Primary dysmenorrhea

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

Long-chain omega-3 fatty acids, found in high levels in certain fish oils, may help protect against common cancers like breast and colon cancer, based on both epidemiological and experimental evidence.

These protective effects are thought to work through various mechanisms, including inhibiting cancer cell growth and promoting cell death, primarily by reducing the production of harmful eicosanoids from omega-6 fatty acids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids as cancer chemopreventive agents. Rose, DP., Connolly, JM.[2022]

References

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

Effect of Celecoxib vs Placebo as Adjuvant Therapy on Disease-Free Survival Among Patients With Breast Cancer: The REACT Randomized Clinical Trial. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Current directions for COX-2 inhibition in breast cancer. [2021]

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

Effects of Celecoxib and Low-dose Aspirin on Outcomes in Adjuvant Aromatase Inhibitor-Treated Patients: CCTG MA.27. [2020]

4. France pubmed.ncbi.nlm.nih.gov

Fish oil augments celecoxib mediated alteration in apoptotic pathway in the initiation phase of 7,12-dimethylbenz(α)anthracene-induced mammary carcinogenesis. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of the role of oxidative stress in chemopreventive action of fish oil and celecoxib in the initiation phase of 7,12-dimethyl benz(α)anthracene-induced mammary carcinogenesis. [2022]

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

Efficacy and safety profile of celecoxib for treating advanced cancers: a meta-analysis of 11 randomized clinical trials. [2022]

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

Biomarker Modulation Study of Celecoxib for Chemoprevention in Women at Increased Risk for Breast Cancer: A Phase II Pilot Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids as cancer chemopreventive agents. [2022]

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

Prevention of colon cancer by low doses of celecoxib, a cyclooxygenase inhibitor, administered in diet rich in omega-3 polyunsaturated fatty acids. [2015]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Celecoxib and fish oil: a combination strategy for decreased inflammatory mediators in early stages of experimental mammary cancer. [2018]