Status:
COMPLETED
Curcumin Biomarker Trial in Head and Neck Cancer
Lead Sponsor:
Louisiana State University Health Sciences Center Shreveport
Collaborating Sponsors:
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-90 years
Phase:
EARLY_PHASE1
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...
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 excit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01160302
Start Date
June 1 2010
End Date
January 1 2016
Last Update
March 2 2016
Active Locations (1)
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1
LSUHSC-Shreveport and Feist-Weiller Cancer Center
Shreveport, Louisiana, United States, 71130