Omega-3 fatty acid + Celecoxib for Breast Cancer
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?
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either omega-3 fatty acid or celecoxib until the morning of surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Celecoxib
- Omega-3 fatty acid
Celecoxib is already approved in United States, European Union, Canada for the following indications:
- Pain relief
- Inflammation
- Osteoarthritis
- Rheumatoid arthritis
- Menstrual cramps
- Colorectal polyps prevention
- Symptomatic relief in osteoarthritis
- Symptomatic relief in rheumatoid arthritis
- Ankylosing spondylitis
- Acute pain
- Primary dysmenorrhea
- Adenomatous polyposis coli
- 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