NCT00365209

Brief Summary

Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Curcumin is a compound found in plants that may prevent colon cancer from forming. This phase II trial is studying how well curcumin works in preventing colon cancer in smokers with aberrant crypt foci.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2006

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

August 27, 2015

Completed
Last Updated

August 27, 2015

Status Verified

March 1, 2014

Enrollment Period

1.9 years

First QC Date

August 16, 2006

Results QC Date

April 18, 2014

Last Update Submit

July 30, 2015

Conditions

Healthy, no Evidence of DiseaseTobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)

    Baseline prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue

    Baseline

  • Post-treatment in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)

    Post-treatment prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue

    At 30 day

Secondary Outcomes (23)

  • Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)

    Baseline

  • Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)

    At 30 Day

  • Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa

    Baseline

  • Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa

    At 30 day

  • Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa

    Baseline

  • +18 more secondary outcomes

Study Arms (2)

2g (curcumin)

EXPERIMENTAL

Patients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Other: laboratory biomarker analysisOther: pharmacological studyDrug: curcumin

4g (curcumin)

EXPERIMENTAL

Patients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Other: laboratory biomarker analysisOther: pharmacological studyDrug: curcumin

Interventions

laboratory biomarker analysisOTHER

Correlative studies

2g (curcumin)4g (curcumin)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
2g (curcumin)4g (curcumin)
curcuminDRUG

Given orally

Also known as: C.I. 75300, C.I. Natural Yellow 3, CU, Diferuloylmethane
2g (curcumin)4g (curcumin)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current smoker with \> 3 pack-year total smoking history
  • Subjects taking NSAIDS or ASA \< 10 days month are eligible but must undergo 14 day washout and refrain from use during the study
  • Subjects who are:
  • Having a clinically indicated screening/surveillance colonoscopy (e.g. due to risk factors, personal history, or symptoms) OR
  • Not having a colonoscopy but are otherwise eligible. These subjects would undergo a flexible sigmoidoscopy.
  • ECOG performance status 0-2 (Karnofsky \> 60%)
  • No severe organ dysfunction which might increase bleeding risk:
  • Demonstrated by: Normal hematologic status (WBC \> 3,000/mm\^3, hemoglobin \> 10.0 gm/dl, and platelet-count \>100,000/mm\^3), normal hepatic function (bilirubin \< 1.5 mg/dl, transaminases \< 1.5x institutional norms), and normal renal function (serum creatinine \< 2.0 mg/dl, documented in clinical chart 28 days prior to enrollment
  • Healthy current smokers (1 cigarette in previous yr) with \> 3-pack year of cigarette smoking and able to provide written informed consent; there are no gender restrictions
  • The effects of curcumin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • NSAID or ASA use \> 10 days /month; any current glucocorticoid use or omega 3-fatty acid supplement use
  • Evidence of the following chronic medical conditions such as:
  • Pregnant or lactating women and/or women who are contemplating pregnancy during the duration of the protocol
  • History of chronic inflammatory bowel disease or prior pelvic irradiation
  • History of peptic ulcer disease (PUD) endoscopically confirmed \< 5 yrs from enrollment date
  • Newly diagnosed colorectal cancer or advanced adenoma \< 1 yr from enrollment
  • Unspecified history of bleeding or coagulation disorder reported by patient or in medical history
  • Hereditary Colon Cancer syndromes (FAP or HNPCC)
  • Participants may not be receiving any other investigational agents
  • History of contact dermatitis from turmeric
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because curcumin is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with curcumin, breastfeeding should be discontinued if the mother is treated with curcumin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Results Point of Contact

Title
Dr. Frank L. Meyskens, Jr.
Organization
University of California, Irvine
flmeyske@uci.edu
714-456-6310

Study Officials

  • Frank Meyskens

    Chao Family Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2008

Study Completion

January 1, 2011

Last Updated

August 27, 2015

Results First Posted

August 27, 2015

Record last verified: 2014-03

Locations

US(1)