NCT01820299

Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Cancers

Interventions

Type	Name	Description
DRUG	Grape Seed Extract	All patients enrolled to the study will take Grape Seed Extract alone for 21 days.
DRUG	Vitamin D	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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-03-28
• Last updated: 2018-05-18

Locations

1 site across 1 country: United States