Curcumin Biomarker Trial in Head and Neck Cancer

NCT ID: NCT01160302

Last Updated: 2016-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2016-01-31

Brief Summary

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).

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Microgranular Curcumin

Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day

Group Type: EXPERIMENTAL

Microgranular Curcumin C3 Complex®

Intervention Type: DRUG

4 grams twice daily for 21-28 days

Interventions

Microgranular Curcumin C3 Complex®

4 grams twice daily for 21-28 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Louisiana State University Health Sciences Center Shreveport

OTHER

Sponsor Role: lead

Responsible Party

Cherie Ann Nathan

Chairman, Dept of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cherie-Ann O Nathan, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

LSUHSC-Shreveport and Feist-Weiller Cancer Center

Locations

LSUHSC-Shreveport and Feist-Weiller Cancer Center

Shreveport, Louisiana, United States

Countries

United States

Other Identifiers

1R21CA137545-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FWCC

Identifier Type: OTHER

Identifier Source: secondary_id

H08-081

Identifier Type: -

Identifier Source: org_study_id