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COX-2 Inhibitor
Omega-3 fatty acid + Celecoxib for Breast Cancer
Phase < 1
Waitlist Available
Led By Virginia Borges, MD, MSc
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological confirmation of breast cancer; for patients with fine needle aspiration (FNA), a core biopsy must be intended
Any clinical stage allowed provided definitive local resection intended and neoadjuvant treatment not intended
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 week
Awards & highlights
Study Summary
This trial looks at whether anti-inflammatory drugs can help reduce the risk of PABC and improve outcomes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include allergic reactions for those sensitive to fish oil or NSAIDs like Celecoxib; digestive issues such as stomach ulcers; increased risk of bleeding; and possibly changes in liver enzymes due to drug metabolism.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer diagnosis was confirmed through a biopsy.
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My cancer can be surgically removed and I am not planned for pre-surgery treatment.
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I am fully active or can carry out light work.
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My anemia is not severe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mean Ki-67 index in patients receiving either omega-3 fatty acid or celecoxib for 1 or more weeks as compared to controls
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 fatty acid
2010
Completed Phase 4
~640
Celecoxib
2019
Completed Phase 4
~1740
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,506 Total Patients Enrolled
27 Trials studying Breast Cancer
6,513 Patients Enrolled for Breast Cancer
Virginia Borges, MD, MScPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to fish, NSAIDs, ASA, or COX 2 inhibitors.My breast cancer diagnosis was confirmed through a biopsy.I have been diagnosed with breast cancer before.I can provide tumor samples or am willing to undergo a biopsy for the study.My cancer can be surgically removed and I am not planned for pre-surgery treatment.I am scheduled for breast cancer surgery at least a week after my diagnosis.I am fully active or can carry out light work.I have an autoimmune condition or take medication that affects my immune system.I don't have bleeding disorders or a history of stomach ulcers, but controlled acid reflux is okay.I am willing to stop taking more than one 1000mg fish oil capsule daily or celecoxib a week before the study starts.I have had a stroke, TIA, or coronary artery disease.I do not have conditions like severe diabetes, COPD, uncontrolled infections, or HIV.I was pregnant when diagnosed with breast cancer and plan to continue the pregnancy.I had cancer other than breast cancer, but it was treated over 5 years ago.I have had Hodgkin's disease treated with a specific type of radiation.My anemia is not severe.I am willing to stop taking fish oil or celebrex if required by the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
- Group 2: Arm II (fish oil)
- Group 3: Arm III (celecoxib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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