Curcumin Biomarker Trial in Head and Neck Cancer

An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma

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).

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.

Inclusion Criteria:

• Subjects with newly diagnosed head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx and have at least one accessible tumor
• Subjects willing to undergo tumor biopsies
• Subjects willing to refrain from nonsteroidal anti-inflammatory drugs (NSAIDS)
• Eastern Co-operative Oncology Group (ECOG) status of 0-3
• Absolute Neutrophil Count ≥ 1500/mm³, Hgb ≥ 10g/dl and Platelet count ≥ 150,000 mm3
• Adequate Renal Function: serum creatinine ≤ 1.5 × upper limit of normal (ULN). Adequate hepatic function: total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 × ULN
• Signed and dated institutional review board approved informed consent form before any protocol specific procedures are performed
• Willingness of subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study and for 2 weeks after last dose of study drug
• No consumption of curcumin-rich foods to subject's knowledge within the previous 48 hours
• Age ≥ 18 years to ≤ 90 years

Exclusion Criteria:

• Subjects receiving anticoagulation therapy
• Known hypersensitivity to curry or black pepper
• Prior cancer therapy in the last 30 day
• Concurrent chemotherapy or radiation
• Severely immunocompromised subjects
• Subjects known to be HIV positive
• any major illness that, in the investigator's judgment, will substantially increase the risk asociated with the subject's participation in the study
• Pregnant or nursing women
• Unwillingness or inability to comply with required study visits and procedures in this protocol