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Curcumin Biomarker Trial in Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Microgranular Curcumin C3 Complex®

About this trial

This is an interventional basic science trial for Head and Neck Cancer focused on measuring cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

LSUHSC-Shreveport and Feist-Weiller Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microgranular Curcumin

Arm Description

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

Outcomes

Primary Outcome Measures

Change in tissue biomarkers

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

Pharmacokinetics of microgranular curcumin

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

Secondary Outcome Measures

Ease of ingestion

Determine if microgranular curcumin can be easily ingested

Full Information

NCT ID

NCT01160302

First Posted

July 8, 2010

Last Updated

March 1, 2016

Sponsor

Louisiana State University Health Sciences Center Shreveport

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01160302

Brief Title

Curcumin Biomarker Trial in Head and Neck Cancer

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 Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Louisiana State University Health Sciences Center Shreveport

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

cancer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Microgranular Curcumin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Microgranular Curcumin C3 Complex®

Intervention Description

4 grams twice daily for 21-28 days

Primary Outcome Measure Information:

Title

Change in tissue biomarkers

Description

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

Time Frame

21-28 days

Title

Pharmacokinetics of microgranular curcumin

Description

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

Time Frame

21-28 days

Secondary Outcome Measure Information:

Title

Ease of ingestion

Description

Determine if microgranular curcumin can be easily ingested

Time Frame

21-28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cherie-Ann O Nathan, MD, FACS

Organizational Affiliation

LSUHSC-Shreveport and Feist-Weiller Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

LSUHSC-Shreveport and Feist-Weiller Cancer Center

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71130

Country

United States

12. IPD Sharing Statement

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Curcumin Biomarker Trial in Head and Neck Cancer

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