NCT01160302

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P75+ for early_phase_1 head-and-neck-cancer

Timeline
Completed

Started Jun 2010

Longer than P75 for early_phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

5.6 years

First QC Date

July 8, 2010

Last Update Submit

March 1, 2016

Conditions

Head and Neck Cancer

Keywords

cancer

Outcome Measures

Primary Outcomes (2)

  • Change in tissue biomarkers

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

    21-28 days

  • Pharmacokinetics of microgranular curcumin

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

    21-28 days

Secondary Outcomes (1)

  • Ease of ingestion

    21-28 days

Study Arms (1)

Microgranular Curcumin

EXPERIMENTAL

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

Drug: Microgranular Curcumin C3 Complex®

Interventions

Microgranular Curcumin C3 Complex®DRUG

4 grams twice daily for 21-28 days

Microgranular Curcumin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSUHSC-Shreveport and Feist-Weiller Cancer Center

Shreveport, Louisiana, 71130, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

  • Cherie-Ann O Nathan, MD, FACS

    LSUHSC-Shreveport and Feist-Weiller Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Dept of Otolaryngology

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 12, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 2, 2016

Record last verified: 2016-03

Locations

US(1)