Curcumin Biomarker Trial in Head and Neck Cancer

This study is ongoing, but not recruiting participants.
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: September 9, 2014
Last verified: September 2014
  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 2015
Estimated Primary Completion Date: July 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160302

Locations
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
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: September 9, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
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 October 01, 2014