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Omega 3 Fatty Acids for Breast Cancer Prevention
N/A
Waitlist Available
Led By Lisa D Yee, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to up to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the effects of two different doses of omega-3 fatty acids on women who are at risk for breast cancer.
Who is the study for?
This trial is for women who've had Stage 0 to III breast cancer that's hormone receptor negative and HER-2/neu positive or negative. They should be done with major treatments like chemotherapy for at least six months, not currently pregnant or nursing, and without other cancers or serious illnesses that could interfere with the study.
What is being tested?
The study tests how different doses of omega 3 fatty acids (DHA and EPA) affect biological markers in breast tissue over a year. Women will be randomly assigned to either a high or low dose group, and researchers will use fine needle aspiration to collect cell samples from their breasts.
What are the potential side effects?
While omega 3 supplements are generally considered safe, potential side effects may include an upset stomach, fishy aftertaste, bleeding if taking high doses or interacting with certain medications like anticoagulants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue
Secondary study objectives
Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue
Changes in cytomorphology and/or cell proliferation of mammary epithelial cells
Side effects data
From 2015 Phase 3 trial • 70 Patients • NCT020415203%
diarrhea
3%
dizzines
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Omega 3 Fatty Acids
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Omega 3 fatty acids - low doseExperimental Treatment1 Intervention
\~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day
Group II: Omega 3 fatty acids - high doseExperimental Treatment1 Intervention
\~5 g EPA+DHA in 5 capsules per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
omega 3 fatty acids
2019
Completed Phase 3
~400
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,500 Total Patients Enrolled
41 Trials studying Breast Cancer
4,797 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,980 Total Patients Enrolled
941 Trials studying Breast Cancer
1,443,157 Patients Enrolled for Breast Cancer
Lisa D Yee, MDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
67 Total Patients Enrolled
2 Trials studying Breast Cancer
67 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have breast implants.You are currently getting treatment for cancer like chemotherapy or radiation therapy.You currently have any other type of cancer that has spread to other parts of your body.You have not been pregnant or breastfeeding for at least one year.You are taking Coumadin or other blood thinners.You have received radiation treatment to both breasts or have had surgery to remove both breasts.You have breast implants, a history of radiation to both breasts, or had both breasts removed, which may make it difficult to collect tissue samples from the breast.You have a health condition that is not under control, like an ongoing infection, heart problems, or mental health issues that could make it hard for you to follow the study rules.You have been taking omega 3 fatty acid supplements or other supplements that could interact with them regularly for the past 3 months.You are allergic to fish.You are currently taking a high dose of aspirin or NSAIDs regularly.You finished chemotherapy or trastuzumab treatment more than six months ago, or radiation therapy more than two months ago, and it has been five years or less since you finished your standard treatment.You had early-stage breast cancer that was estrogen receptor negative and progesterone receptor negative, and you finished treatment like surgery, radiation, or chemotherapy.You had a mammogram in the past eight months that did not show signs of breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Omega 3 fatty acids - high dose
- Group 2: Omega 3 fatty acids - low dose
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.
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