An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Change in tissue biomarkers
Change in tissue levels, between pre- and post-treatment biopsy
21-28 days
No
Cherie-Ann O Nathan, MD, FACS
Principal Investigator
LSUHSC-Shreveport and Feist-Weiller Cancer Center
United States: Institutional Review Board
H08-081
NCT01160302
June 2010
July 2013
Name | Location |
---|---|
LSUHSC-Shreveport and Feist-Weiller Cancer Center | Shreveport, Louisiana 71130 |