Curcumin Biomarker Trial in Head and Neck Cancer

Completed · Early Phase 1

Conditions studied: Head and Neck Cancer

In brief

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).

Key facts

Study ID

NCT01160302

Run by

Louisiana State University Health Sciences Center Shreveport

People needed

33

Starts

2010-06-01

Expected to finish

2016-01-01

Last updated by the study team

2016-03-02

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• LSUHSC-Shreveport and Feist-Weiller Cancer Center — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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