Clinical trial NCT01160302: Curcumin Biomarker Trial in Head and Neck Cancer
Official title: An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Head and Neck Cancer
Keywords: cancer
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
Collaborators: name: Feist-Weiller Cancer Center at Louisiana State University Health Sciences
name: National Cancer Institute (NCI)
First posted: 2010-07-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Change in tissue biomarkers
timeFrame: 21-28 days
measure: Pharmacokinetics of microgranular curcumin
timeFrame: 21-28 days
Secondary outcomes:
measure: Ease of ingestion
timeFrame: 21-28 days
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: LSUHSC-Shreveport and Feist-Weiller Cancer Center
state: Louisiana
Study officials:
affiliation: LSUHSC-Shreveport and Feist-Weiller Cancer Center
name: Cherie-Ann O Nathan, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: