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| ID | Type | Description | Link |
|---|---|---|---|
| HSC20150602H | Other Identifier | UT Health Science Center Institutional Review Board |
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Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole | Active Comparator | Letrozole 2.5 mg by mouth daily for 30 days. |
|
| Fish Oil | Active Comparator | Fish oil 2700 mg by mouth daily for 30 days. |
|
| Letrozole and Fish Oil | Active Comparator | Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Aromatase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in levels of aromatase target gene. | 30 Days | |
| Change in serum levels of PGE2 (prostaglandin E2). | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Brenner, MD, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Cancer Center at Texas Medical Center | Houston | Texas | 77030 | United States | ||
| Mays Cancer Center, UT Health San Antonio |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D005395 | Fish Oils |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Fish Oil | Dietary Supplement | Omega-3 free fatty acid |
|
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009821 | Oils |
| D008055 | Lipids |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |