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This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation throughout the entire body) in subjects with advanced cancer.
This study will look at oligomeric procyanidin complex (OPC) and vitamin D3. OPC is the major part of Grape Seed Extract (GSE). Researchers are in looking at the combination of GSE and vitamin D in subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). Researchers will examine the safety of the GSE and vitamin D when GSE is given at different doses. Researchers will also look at the effects of GSE and vitamin D on your quality of life and your body. In particular, they will look at differences in biomarkers in your blood and urine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grape Seed Extract and Vitamin D | Experimental | All patients will take Grape Seed Extract from Day 1 to Day 21. All patients will take Grape Seed Extract and Vitamin D together from Day 22 until Day 64. For all patients on the study, patients will take Vitamin D once a day at a dose of 4000IU. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grape Seed Extract | Drug | All patients enrolled to the study will take Grape Seed Extract alone for 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximally-tolerated dose of Grape Seed Extract in Patients with Solid Tumors | Decisions to escalate or expand a dose level will be based only on the GSE-only treatment period (day 1-21). To be evaluable for toxicity, a patient must receive at least 3 weeks of GSE treatment, or have experienced dose-limiting toxicity (DLT). All patients enrolled are to be fully followed for toxicity, but any patients who are not evaluable for toxicity will be replaced. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| IL6 Response | Plasma IL-6 levels before and after 21 days and 63 days of GSE treatment will be quantified to estimate the dose response relationship between GSE dose and reduction in inflammation. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Other Inflammatory Markers | Other markers that will be measured will include serum CRP, albumin, AGEs (advanced glycation end products), rAGE (soluble receptor for AGEs), 25-OH-vitamin D3, and urine for oxidative damage DNA biomarkers (urinary 8-oxoGua and 8-oxodG). Correlations between dose and change in these parameters from before to 21, 63 days after start of GSE dosing will be described. |
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 | 29412 | United States |
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| ID | Term |
|---|---|
| D056604 | Grape Seed Extract |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Vitamin D | Drug | From Day 22 until Day 64 of the study, patients will take Grape Seed Extract and Vitamin D together. Patients will take Vitamin D once at a day at 4000 IU. |
|
| 2 years |
| Quality of Life Questionnaires | Serial QOL assessments will be made by the FACT series of QOL questionnaires | 2 years |
| Effect of Vitamin D3 on Anti-Inflammatory Effects of GSE | The ability of a fixed dose of vitamin D3 (4000 IU daily) to further suppress IL-6 levels in subjects on GSE treatment will be evaluated. | 2 years |
| D004364 |
| Pharmaceutical Preparations |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |