Curcumin Biomarker Trial in Head and Neck Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Microgranular Curcumin C3 Complex®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microgranular Curcumin<br>Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day | Drug: Microgranular Curcumin C3 Complex®<br>* 4 grams twice daily for 21-28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tissue biomarkers | Change in tissue levels, between pre- and post-treatment biopsy | 21-28 days | 
| Pharmacokinetics of microgranular curcumin | Determine whether biologically active levels of curcumin can be achieved in head and neck tumors | 21-28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of ingestion | Determine if microgranular curcumin can be easily ingested | 21-28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer