Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects

Study Overview
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Brief Summary
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Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Letrozole
* Dietary Supplement: Fish Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Letrozole<br>Letrozole 2.5 mg by mouth daily for 30 days. | Drug: Letrozole<br>* Aromatase inhibitor<br>* Other names: Femara;|
| Active Comparator: Fish Oil<br>Fish oil 2700 mg by mouth daily for 30 days. | Dietary Supplement: Fish Oil<br>* Omega-3 free fatty acid<br>* Other names: Omega-3;|
| Active Comparator: Letrozole and Fish Oil<br>Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days. | Drug: Letrozole<br>* Aromatase inhibitor<br>* Other names: Femara;Dietary Supplement: Fish Oil<br>* Omega-3 free fatty acid<br>* Other names: Omega-3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels of aromatase target gene. |  | 30 Days | 
| Change in serum levels of PGE2 (prostaglandin E2). |  | 30 Days |