Curcumin Biomarker Trial in Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Drug: Microgranular Curcumin C3 Complex®
- Registration Number
- NCT01160302
- Lead Sponsor
- Louisiana State University Health Sciences Center Shreveport
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Microgranular Curcumin Microgranular Curcumin C3 Complex® Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Ease of ingestion 21-28 days Determine if microgranular curcumin can be easily ingested
Trial Locations
- Locations (1)
LSUHSC-Shreveport and Feist-Weiller Cancer Center
🇺🇸Shreveport, Louisiana, United States
LSUHSC-Shreveport and Feist-Weiller Cancer Center🇺🇸Shreveport, Louisiana, United States