Curcumin Biomarker Trial in Head and Neck Cancer

Louisiana State University Health Sciences Center Shreveport

Status and phase: Completed; Early Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: Microgranular Curcumin C3 Complex®

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01160302

FWCC (Other Identifier)

H08-081

1R21CA137545-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Microgranular Curcumin

Experimental group

Description:

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

Treatment:

Drug: Microgranular Curcumin C3 Complex®