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

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