Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects
A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
2 other identifiers
interventional
24
1 country
2
Brief Summary
Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 breast-cancer
Started Apr 2016
Typical duration for early_phase_1 breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2020
CompletedJuly 17, 2023
July 1, 2023
3.9 years
August 11, 2015
July 13, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Change in levels of aromatase target gene.
30 Days
Change in serum levels of PGE2 (prostaglandin E2).
30 Days
Study Arms (3)
Letrozole
ACTIVE COMPARATORLetrozole 2.5 mg by mouth daily for 30 days.
Fish Oil
ACTIVE COMPARATORFish oil 2700 mg by mouth daily for 30 days.
Letrozole and Fish Oil
ACTIVE COMPARATORLetrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
Interventions
Eligibility Criteria
You may qualify if:
- At least 18 years of age.
- 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
You may not qualify if:
- Cachexia
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Houston Methodist Cancer Center at Texas Medical Center
Houston, Texas, 77030, United States
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Brenner, MD, PhD
Principal Investigator
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2015
First Posted
September 2, 2015
Study Start
April 1, 2016
Primary Completion
March 11, 2020
Study Completion
March 26, 2020
Last Updated
July 17, 2023
Record last verified: 2023-07