Curcumin Biomarker Trial in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160302
• Other study ID #: H08-081
• Secondary ID: 1R21CA137545-01A
• Status: Completed
• Phase: Phase 0
• First received: July 8, 2010
• Last updated: March 1, 2016
• Start date: June 2010
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Louisiana State University Health Sciences Center Shreveport
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Microgranular Curcumin C3 Complex®
4 grams twice daily for 21-28 days

Locations

Country	Name	City	State
United States	LSUHSC-Shreveport and Feist-Weiller Cancer Center	Shreveport	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center Shreveport	Feist-Weiller Cancer Center at Louisiana State University Health Sciences, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tissue biomarkers	Change in tissue levels, between pre- and post-treatment biopsy	21-28 days	No
Primary	Pharmacokinetics of microgranular curcumin	Determine whether biologically active levels of curcumin can be achieved in head and neck tumors	21-28 days	No
Secondary	Ease of ingestion	Determine if microgranular curcumin can be easily ingested	21-28 days	No