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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

Phase 0
18 Years
90 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Change in tissue biomarkers

Outcome Description:

Change in tissue levels, between pre- and post-treatment biopsy

Outcome Time Frame:

21-28 days

Safety Issue:


Principal Investigator

Cherie-Ann O Nathan, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

LSUHSC-Shreveport and Feist-Weiller Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

July 2013

Related Keywords:

  • Head and Neck Cancer
  • cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



LSUHSC-Shreveport and Feist-Weiller Cancer CenterShreveport, Louisiana  71130