Curcumin Biomarker Trial in Head and Neck Cancer

• Sponsor: Louisiana State University Health Sciences Center Shreveport (Other)
• Overall Status: Completed
• CT.gov ID: NCT01160302
• Collaborator: Feist-Weiller Cancer Center at Louisiana State University Health Sciences (Other), National Cancer Institute (NCI) (NIH)
• Enrollment: 33
• Location: 1
• Arm: 1
• Duration (Months): 67
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: Microgranular Curcumin C3 Complex®	Early Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in tissue biomarkers [21-28 days]

   Change in tissue levels, between pre- and post-treatment biopsy

2. Pharmacokinetics of microgranular curcumin [21-28 days]

   Determine whether biologically active levels of curcumin can be achieved in head and neck tumors

Secondary Outcome Measures

1. Ease of ingestion [21-28 days]

   Determine if microgranular curcumin can be easily ingested

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Cherie-Ann O Nathan, MD, FACS, LSUHSC-Shreveport and Feist-Weiller Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cherie Ann Nathan, Chairman, Dept of Otolaryngology, Louisiana State University Health Sciences Center Shreveport
• ClinicalTrials.gov Identifier: NCT01160302
• Other Study ID Numbers: H08-081; 1R21CA137545-01A2; FWCC
• First Posted: Jul 12, 2010
• Last Update Posted: Mar 2, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Cherie Ann Nathan, Chairman, Dept of Otolaryngology, Louisiana State University Health Sciences Center Shreveport: cancer
• Additional relevant MeSH terms: Head and Neck Neoplasms; Curcumin

Study Results

No Results Posted as of Mar 2, 2016