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Curcumin Biomarker Trial in Head and Neck Cancer

This study has been completed.
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Cherie Ann Nathan, Louisiana State University Health Sciences Center Shreveport Identifier:
First received: July 8, 2010
Last updated: March 1, 2016
Last verified: March 2016
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).

Condition Intervention Phase
Head and Neck Cancer
Drug: Microgranular Curcumin C3 Complex®
Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • Change in tissue biomarkers [ Time Frame: 21-28 days ]
    Change in tissue levels, between pre- and post-treatment biopsy

  • Pharmacokinetics of microgranular curcumin [ Time Frame: 21-28 days ]
    Determine whether biologically active levels of curcumin can be achieved in head and neck tumors

Secondary Outcome Measures:
  • Ease of ingestion [ Time Frame: 21-28 days ]
    Determine if microgranular curcumin can be easily ingested

Enrollment: 33
Study Start Date: June 2010
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microgranular Curcumin
Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day
Drug: Microgranular Curcumin C3 Complex®
4 grams twice daily for 21-28 days

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01160302

United States, Louisiana
LSUHSC-Shreveport and Feist-Weiller Cancer Center
Shreveport, Louisiana, United States, 71130
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
National Cancer Institute (NCI)
Principal Investigator: Cherie-Ann O Nathan, MD, FACS LSUHSC-Shreveport and Feist-Weiller Cancer Center
  More Information

Responsible Party: Cherie Ann Nathan, Chairman, Dept of Otolaryngology, Louisiana State University Health Sciences Center Shreveport Identifier: NCT01160302     History of Changes
Other Study ID Numbers: H08-081
1R21CA137545-01A2 ( US NIH Grant/Contract Award Number )
FWCC ( Other Identifier: Feist-Weiller Cancer Center )
Study First Received: July 8, 2010
Last Updated: March 1, 2016

Keywords provided by Louisiana State University Health Sciences Center Shreveport:

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017