Curcumin Biomarker Trial in Head and Neck Cancer

This study is currently recruiting participants.
Verified October 2013 by Louisiana State University Health Sciences Center Shreveport
Sponsor:
Collaborators:
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Information provided by (Responsible Party):
Cherie Ann Nathan, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT01160302
First received: July 8, 2010
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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
Dietary Supplement: Microgranular Curcumin C3 Complex®
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
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 ] [ Designated as safety issue: No ]
    Change in tissue levels, between pre- and post-treatment biopsy

  • Pharmacokinetics of microgranular curcumin [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Determine if microgranular curcumin can be easily ingested


Estimated Enrollment: 15
Study Start Date: June 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microgranular Curcumin
Consume microgranular curcumin
Dietary Supplement: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160302

Contacts
Contact: Cherie-Ann O. Nathan, MD, FACS (318) 675-6262 cnatha@lsuhsc.edu

Locations
United States, Louisiana
LSUHSC-Shreveport and Feist-Weiller Cancer Center Recruiting
Shreveport, Louisiana, United States, 71130
Contact: Cherie-Ann O Nathan, MD, FACS    318-675-6262    cnatha@lsuhsc.edu   
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Investigators
Principal Investigator: Cherie-Ann O Nathan, MD, FACS LSUHSC-Shreveport and Feist-Weiller Cancer Center
  More Information

No publications provided

Responsible Party: Cherie Ann Nathan, Chairman, Dept of Otolaryngology, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT01160302     History of Changes
Other Study ID Numbers: H08-081, 1R21CA137545-01A2, FWCC
Study First Received: July 8, 2010
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Louisiana State University Health Sciences Center Shreveport:
cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014