Curcumin Biomarker Trial in Head and Neck Cancer

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

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).

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Microgranular Curcumin C3 Complex®

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71130
      • LSUHSC-Shreveport and Feist-Weiller Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center Shreveport
• Collaborators: National Cancer Institute (NCI); 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

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: July 8, 2010
• First Submitted That Met QC Criteria: July 8, 2010
• First Posted (ESTIMATE): July 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 2, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: H08-081; 1R21CA137545-01A2 (NIH); FWCC (OTHER: Feist-Weiller Cancer Center)