Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects
NCT ID: NCT02538484
Last Updated: 2023-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
24 participants
INTERVENTIONAL
2016-04-30
2020-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Letrozole
Letrozole 2.5 mg by mouth daily for 30 days.
Letrozole
Aromatase inhibitor
Fish Oil
Fish oil 2700 mg by mouth daily for 30 days.
Fish Oil
Omega-3 free fatty acid
Letrozole and Fish Oil
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
Letrozole
Aromatase inhibitor
Fish Oil
Omega-3 free fatty acid
Interventions
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Letrozole
Aromatase inhibitor
Fish Oil
Omega-3 free fatty acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postmenopausal as confirmed in medical history
* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB (Institutional Review Board)/Ethics Committee.
* Estrogen receptor positive breast cancer. Body mass index of 30 or greater.
* Consented for tissue collection on CTRC (Cancer Therapy and Research Center) repository 07-32
Exclusion Criteria
* Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
* Chronic use of NSAIDs (nonsteroidal anti-inflammatory drugs) aspirin or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
* Any NSAIDs aspirin or omega-3 free fatty acid supplementation within the last 14 days
* History of medical noncompliance
* Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days
18 Years
FEMALE
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Andrew Brenner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Houston Methodist Cancer Center at Texas Medical Center
Houston, Texas, United States
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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HSC20150602H
Identifier Type: OTHER
Identifier Source: secondary_id
CTMS# 15-2100
Identifier Type: -
Identifier Source: org_study_id
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