Curcumin Biomarker Trial in Head and Neck Cancer
There is considerable evidence that turmeric consumption may have a protective effect against cancer progression. The purpose of this study is to examine the short-term effects of supplementation with a turmeric extract, Curcumin C3 Complex®, on biomarkers of head and neck squamous cell carcinoma (HNSCC).
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma|
- Change in tissue biomarkers [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]Change in tissue levels, between pre- and post-treatment biopsy
- Pharmacokinetics of microgranular curcumin [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]Determine whether biologically active levels of curcumin can be achieved in head and neck tumors
- Ease of ingestion [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]Determine if microgranular curcumin can be easily ingested
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Microgranular Curcumin
Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day
Drug: Microgranular Curcumin C3 Complex®
4 grams twice daily for 21-28 days
This is an open label, exploratory biomarker trial of the food substances Curcumin C3 Complex® in subjects with newly diagnosed HNSCC. Curcumin, a novel safe nutritional interventional agent has exciting potential usage as a preventive/adjuvant agent, and prevents tumor formation by inhibiting an important molecular pathway that is shown to cause cancer progression, which we will test as a tumor marker in this clinical trial.
The primary objective is to evaluate biomarker response of HNSCC patients to the food substances Curcumin C3 Complex®. This will be done by comparing post-intervention values to baseline values. In addition, we will determine the levels of curcumin and its metabolites in tumor and adjacent tissue.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160302
|United States, Louisiana|
|LSUHSC-Shreveport and Feist-Weiller Cancer Center|
|Shreveport, Louisiana, United States, 71130|
|Principal Investigator:||Cherie-Ann O Nathan, MD, FACS||LSUHSC-Shreveport and Feist-Weiller Cancer Center|