42 Participants Needed

Omega-3 fatty acid + Celecoxib for Breast Cancer

Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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 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.12345

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.56789

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.136710

Who Is on the Research Team?

VB

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
See 12 more

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.
See 8 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (celecoxib)Experimental Treatment1 Intervention
Patients receive celecoxib by mouth twice a day until the morning of surgery.
Group II: Arm II (fish oil)Experimental Treatment1 Intervention
Patients receive omega-3 fatty acid by mouth everyday until the morning of surgery.
Group III: Arm IActive Control1 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

Find a Clinic Near You

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

Citations

Effect of Celecoxib vs Placebo as Adjuvant Therapy on Disease-Free Survival Among Patients With Breast Cancer: The REACT Randomized Clinical Trial. [2022]
Current directions for COX-2 inhibition in breast cancer. [2021]
Effects of Celecoxib and Low-dose Aspirin on Outcomes in Adjuvant Aromatase Inhibitor-Treated Patients: CCTG MA.27. [2020]
Fish oil augments celecoxib mediated alteration in apoptotic pathway in the initiation phase of 7,12-dimethylbenz(α)anthracene-induced mammary carcinogenesis. [2020]
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]
Efficacy and safety profile of celecoxib for treating advanced cancers: a meta-analysis of 11 randomized clinical trials. [2022]
Biomarker Modulation Study of Celecoxib for Chemoprevention in Women at Increased Risk for Breast Cancer: A Phase II Pilot Study. [2023]
Omega-3 fatty acids as cancer chemopreventive agents. [2022]
Prevention of colon cancer by low doses of celecoxib, a cyclooxygenase inhibitor, administered in diet rich in omega-3 polyunsaturated fatty acids. [2015]
Celecoxib and fish oil: a combination strategy for decreased inflammatory mediators in early stages of experimental mammary cancer. [2018]
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