Head and Neck Cancer
Conditions
Keywords
cancer
Brief summary
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).
Detailed description
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.
Interventions
DRUGMicrogranular Curcumin C3 Complex®
4 grams twice daily for 21-28 days
Sponsors
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
National Cancer Institute (NCI)
Louisiana State University Health Sciences Center Shreveport
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tissue biomarkers | 21-28 days | Change in tissue levels, between pre- and post-treatment biopsy |
| Pharmacokinetics of microgranular curcumin | 21-28 days | Determine whether biologically active levels of curcumin can be achieved in head and neck tumors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of ingestion | 21-28 days | Determine if microgranular curcumin can be easily ingested |
Countries
United States
Outcome results
None listed