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Brief Title: Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer
Official Title: Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer
Study ID: NCT01820299
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical University of South Carolina, Charleston, South Carolina, United States
Name: Michael Lilly, MD
Affiliation: Medical University of South Carolina
Role: PRINCIPAL_INVESTIGATOR