Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects
Purpose
Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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
- 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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Letrozole |
Letrozole 2.5 mg by mouth daily for 30 days. |
|
|
Active Comparator Fish Oil |
Fish oil 2700 mg by mouth daily for 30 days. |
|
|
Active Comparator Letrozole and Fish Oil |
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days. |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center at San Antonio
Study Contact
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.