Curcumin Biomarker Trial in Head and Neck Cancer

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Louisiana State University Health Sciences Center Shreveport
• Collaborators: Feist-Weiller Cancer Center at Louisiana State University Health Sciences; National Cancer Institute (NCI)
• Treatments: Curcumin

Criteria

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