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Omega-3 Fatty Acid Supplement
Omega-3 Supplementation for Breast Cancer Risk Reduction
N/A
Waitlist Available
Led By Lauren Nye, MD
Research Sponsored by Lauren Nye
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women age 21 - 40 must be pre-menopausal as defined as having intact ovaries with regular menses or if not menstruating, have a premenopausal status confirmed by serum follicle-stimulating hormone (FSH) and estradiol.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial studies if omega-3 fatty acids are safe & effective for pre-menopausal women at high risk of breast cancer + considering pregnancy.
Who is the study for?
This trial is for premenopausal women aged 21-40 at high risk for breast cancer who are considering future pregnancy. They must be one year from pregnancy and breastfeeding, have regular menses or confirmed premenopausal hormone levels, and a significant family history of breast cancer or other specified risk factors. Participants should be willing to take omega-3 supplements provided by the study but cannot be currently pregnant, breastfeeding, undergoing fertility treatments, on anticoagulation therapy, have certain breast surgeries or active cancers.Check my eligibility
What is being tested?
The study tests the feasibility of moderate dose omega-3 fatty acid supplementation in premenopausal women at high risk for breast cancer with plans for future pregnancies. It aims to assess participant compliance with taking omega-3 supplements and to identify potential new biomarkers affected by these supplements in this specific group.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of omega-3 supplementation may include a fishy aftertaste, gastrointestinal discomfort such as bloating or diarrhea, and an increased risk of bleeding if taken in high doses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 21-40 and am pre-menopausal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Follow-up visit completion rate
Secondary outcome measures
Omega-3 fatty acids
Identify presence of biomarkers
Incidence of microbiome in collected breast tissue
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Omega-3 SupplementationExperimental Treatment1 Intervention
Participants will take the dose of omega-3 supplementation (600mg DHA and 300mg EPA) daily for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 Supplementation
2016
Completed Phase 4
~180
Find a Location
Who is running the clinical trial?
Lauren NyeLead Sponsor
University of Kansas Medical CenterOTHER
462 Previous Clinical Trials
169,196 Total Patients Enrolled
22 Trials studying Breast Cancer
4,499 Patients Enrolled for Breast Cancer
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,444 Total Patients Enrolled
32 Trials studying Breast Cancer
8,873 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received radiation therapy to both of my breasts.I am at high risk for breast cancer due to family history or previous biopsy results.I am a woman currently diagnosed with cancer.I am a woman considering having children in the future.I am a woman currently taking blood thinners.I have bilateral breast implants or tram flap reconstruction.I have a breast lump that could be cancer, but it's not confirmed yet.I am a woman aged 21-40 and am pre-menopausal.I have not been pregnant or breast-fed in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Omega-3 Supplementation
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.
Are older individuals being incorporated into this experiment?
"This clinical trial is enrolling individuals aged 21 to 40."
Answered by AI
What criteria do potential participants need to meet in order to qualify for this clinical experiment?
"Candidates between 21 and 40 years old who have been diagnosed with breast cancer are encouraged to apply for this trial. In total, 11 people will be recruited into the study."
Answered by AI
Are there opportunities for participants in this research project?
"According to data on clinicaltrials.gov, this clinical trial is not presently accepting applicants. The listing was initially posted in February of 2018 and last modified in May of 2023; however, there are 2,693 other studies that are currently open for recruitment."
Answered by AI
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