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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two anti-inflammatory treatments—fish oil capsules and celecoxib (also known as Celebrex)—affect breast cancer associated with pregnancy. Researchers aim to determine if these treatments can reduce inflammation and the cancer’s potential to spread. Participants will join one of three groups: observation only, fish oil, or celecoxib. Those diagnosed with breast cancer and planning surgery at least a week from diagnosis might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants a chance to contribute to groundbreaking research.

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.

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

Research has shown that omega-3 fatty acids, commonly found in fish oil, are usually safe for people to take. Studies have explored their potential to lower breast cancer risk, and they generally have few side effects. However, more research is needed to confirm their effectiveness in reducing cancer risk.

Celecoxib, a COX-2 inhibitor, has undergone testing for safety in breast cancer patients. Research indicates it is generally safe, with no major increase in serious side effects compared to a placebo. However, it may not always prevent breast cancer from returning.

Early studies suggest that both omega-3 fatty acids and celecoxib are safe for people, with few side effects. Still, consulting a healthcare provider before starting any new treatments is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer novel approaches to tackling breast cancer. Celecoxib, a nonsteroidal anti-inflammatory drug, is being explored for its potential anti-cancer properties, targeting inflammation-related pathways that could inhibit tumor growth. On the other hand, omega-3 fatty acids, commonly found in fish oil, are being investigated for their ability to reduce inflammation and possibly slow cancer progression by altering cell membrane composition and function. These treatments are unique because they aim to exploit anti-inflammatory mechanisms, which are different from the traditional chemotherapy and hormone therapies typically used for breast cancer.

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

Research has shown that omega-3 fatty acids, which participants in this trial may receive, might help fight breast cancer by reducing inflammation and slowing cancer cell growth. Some studies have found that fish oil, rich in omega-3s, can lower the risk of breast cancer and slow cancer cell development. Omega-3s have also improved certain health indicators in individuals undergoing or after breast cancer treatment.

Celecoxib, another treatment option in this trial, has shown mixed results in treating breast cancer. Some studies suggest it might stop cancer cells from growing by blocking certain enzymes and cutting off the blood supply to tumors. However, other research found no significant difference in survival rates between patients taking celecoxib and those who did not. ^{1 3 4 6 7}

Who Is on the Research Team?

Virginia Borges, MD, MSc

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6208493/

Celecoxib in breast cancer prevention and therapy - PMC Thus, celecoxib shows an anticancer activity and seems to be effective in anticancer treatment. Bocca et al assessed the antiproliferative activity of celecoxib ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9578006/

Celecoxib may be a viable treatment option for breast ... Celecoxib has shown efficacy in preclinical studies of breast cancer and also as a chemopreventive agent in epidemiological investigations.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00045591

Celecoxib in Treating Women With Metastatic or Recurrent ... RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2781890

Effect of Celecoxib vs Placebo as Adjuvant Therapy on ... Disease-free survival events were reported for 487 patients (19%): 18% for those receiving celecoxib vs 19% for those receiving placebo, a ...

5. uspharmacist.com uspharmacist.com/article/celecoxib-safe-but-not-effective-for-breast-cancer

Celecoxib Safe, but Not Effective, for Breast Cancer There were also no differences in OS between the two groups, with 5-year OS of 90% in the celecoxib group and 91% in the placebo group. ER ...

6. mdpi.com mdpi.com/1718-7729/29/9/482

The Efficacy and Safety of Celecoxib in Addition ... Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer Might Worsen Outcomes Differentially by COX-2 Expression and ER Status ...

7. cancerresearchuk.org cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-celecoxib-for-women-with-breast-cancer

A trial looking at celecoxib for women with breast cancer ... The trial team found that taking celecoxib for 2 years didn't stop HER2 negative breast cancer coming back.