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
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Change in levels of aromatase target gene.
Study Overview
Brief Summary
Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.
Detailed Description
Prospective, comparative, three arm, short term, non-interventional study with correlative biomarker endpoints. Sixty (60) obese (≥ 30 BMI) newly diagnosed ER+ postmenopausal breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Arms & Interventions
Letrozole
Letrozole 2.5 mg by mouth daily for 30 days.
Intervention: Letrozole (Drug)
Fish Oil
Fish oil 2700 mg by mouth daily for 30 days.
Intervention: Fish Oil (Dietary Supplement)
Letrozole and Fish Oil
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
Intervention: Letrozole (Drug)
Letrozole and Fish Oil
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
Intervention: Fish Oil (Dietary Supplement)
Outcomes
Primary Outcomes
Change in levels of aromatase target gene.
Time Frame: 30 Days
Change in serum levels of PGE2 (prostaglandin E2).
Time Frame: 30 Days
Secondary Outcomes
No secondary outcomes reported