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Original principal investigator departed institution and concluded the study upon departure.
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The purpose of this study is to look at the effects that the study drug (OPC) has on AGE levels in patients with ER+ metastatic breast cancer.
AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if certain drug (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC | Experimental | During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC | Drug | OPC is a derivative of grape seed extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| AGE level reduction | The primary objective is to determine if the test agents are able to reduce AGE levels by at least 30% in th 50% or more of test subjects. | 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between AGE level and changes to BMI | Changes in AGE levels and BMI will be described using graphs and other models. | 85 days |
| Correlation between AGE level and insulin resistance (HOMA-IR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lilly, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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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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Changes in AGE levels and HOMA-IR will be described using graphs and other models.
| 85 days |
| Correlation between AGE level and A1C | Changes in AGE levels and A1C will be described using graphs and other models. | 85 days |
| Correlation between AGE level and lipids | Changes in AGE levels and lipids will be described using graphs and other models. | 85 days |
| Correlation between AGE level and diet | Changes in AGE levels and diet will be described using graphs and other models. Diet will be assessed by using the NIH "Eating at America's Table Study Quick Food Scan" and the NCI "Quick Food Scan" | 85 days |
| Correlation between AGE level and quality of life | Measured by FACT-B quality of life questionnaire | 85 days |
| Correlation between AGE level and plasma IL6 | Changes in AGE levels and IL6 will be described using graphs and other models. | 85 days |
| Correlation between AGE level and leptin | Changes in AGE levels and leptin will be described using graphs and other models. | 85 days |
| Correlation between AGE level and c-reactive protein (CRP) | Changes in AGE levels and CRP will be described using graphs and other models. | 85 days |
| Correlation between AGE level and malondialdehyde (MDA) | Changes in AGE levels and MDA will be described using graphs and other models. | 85 days |
| Correlation between AGE level and oxLDLs (low density lipoprotein) | Changes in AGE levels and oxLDLs will be described using graphs and other models. | 85 days |
| Correlation between AGE level and sRAGE (soluble receptor for AGE) | Changes in AGE levels and sRAGE will be described using graphs and other models. | 85 days |
| Frequency of adverse events as assessed by CTCAE v. 4 | Toxicities will be tabulated by type, grade and the visit at which they occurred. | 85 days |
| Tumor response to treatment as assessed by RECIST 1.1 or MD Anderson criteria | The anti-tumor response will be measured by comparing baseline and post-treatment imaging using RECIST 1.1 or MD Anderson criteria for bone only disease. | 85 days |
| D017437 |
| Skin and Connective Tissue Diseases |