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Omega-3 Supplements for Breast Cancer Side Effects (ALTA Trial)
Phase 2
Waitlist Available
Led By Lynn Henry, MD, PhD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Completion of chemotherapy, if indicated. Concurrent use of radiation therapy, LHRHa therapy, anti-HER2 therapy, PARP inhibitor, and CDK4/6 inhibitor therapy is permitted. Prior tamoxifen is permitted.
Agree to avoid taking omega-3 fatty acid supplements from sources outside the trial during study participation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months after start of ai therapy
Awards & highlights
ALTA Trial Summary
This trial is testing whether omega-3 fatty acid supplements can help reduce the side effects of aromatase inhibitor medications for breast cancer.
Who is the study for?
This trial is for postmenopausal women aged 18 or older who have completed breast cancer surgery and may be starting aromatase inhibitor therapy soon. It's also open to high-risk individuals planning preventive treatment. Participants must not take other omega-3 supplements during the study and should be able to fill out questionnaires in English.Check my eligibility
What is being tested?
The trial is testing if taking omega-3 fatty acid supplements can reduce joint pain and stiffness associated with aromatase inhibitor medications, which are used for treating hormone receptor positive breast cancer or as a preventive measure in high-risk patients.See study design
What are the potential side effects?
While the side effects of omega-3 fatty acid supplements aren't detailed here, they typically include mild digestive issues, fishy aftertaste, and possibly increased bleeding risk if taken in high doses.
ALTA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
If you need chemotherapy, you must have already completed it before joining the trial. You are allowed to receive certain other types of therapy while participating in the trial.
Select...
You won't take any omega-3 supplements from outside the clinical trial while participating.
ALTA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 months after start of ai therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months after start of ai therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in percentage of total fatty acids for each polyunsaturated fatty acid (PUFA) group from start of Omega-3 Fatty Acid (O3-FA) supplementation to 3 months of O3-FA
Secondary outcome measures
Ai Chi Therapy
Change in percentage of total fatty acids for each PUFA group from baseline to 6 months of Aromatase Inhibitor (AI) (3 months of AI alone + 3 months of AI with O3-FA supplementation)
Ai Chi Therapy
+2 moreALTA Trial Design
1Treatment groups
Experimental Treatment
Group I: Omega 3 fatty acid supplementExperimental Treatment1 Intervention
Omega-3 ethyl esters orally daily (containing 465 mg eicosapentaenoic acid [EPA] and 375 mg docosahexaenoic acid [DHA] per capsule,supplied as 4 x 1gm capsule)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 fatty acid supplement
2020
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
292 Previous Clinical Trials
24,040 Total Patients Enrolled
32 Trials studying Breast Cancer
3,911 Patients Enrolled for Breast Cancer
Lynn Henry, MD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
1 Previous Clinical Trials
82 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being sought for this experiment?
"Unfortunately, this specific study is not seeking any more patients at the moment. Although, there are 1451 other studies that are still recruiting individuals. This particular trial was originally posted on 7/28/2020 and updated for the last time on 10/6/2022 according to clinicaltrials.gov"
Answered by AI
What does the FDA think of Omega-3 fatty acid pills?
"While Phase 2 trials don't have the same level of data supporting efficacy, there is still some clinical evidence backing Omega-3 fatty acid supplements as a safe treatment. Our team at Power gave it a score of 2."
Answered by AI
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