This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00365209
First received: August 16, 2006
Last updated: July 30, 2015
Last verified: March 2014
Results First Received: April 18, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Healthy, no Evidence of Disease
Tobacco Use Disorder
Interventions: Other: laboratory biomarker analysis
Other: pharmacological study
Drug: curcumin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is a 2-stage study. In Stage1, there are 23 enrolled participants who received 2 g curcumin. In Stage2, there are addictional 21 enrolled participants who received 4 g curcumin.

Reporting Groups
  Description
Curcumin

Stage 1: Particpants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

Stage 2: Particpants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally


Participant Flow for 2 periods

Period 1:   Stage 1: Receiving 2g Curcumin
    Curcumin
STARTED   23 
COMPLETED   21 
NOT COMPLETED   2 

Period 2:   Stage 2: Receiving 4g Curcumin
    Curcumin
STARTED   21 
COMPLETED   19 
NOT COMPLETED   2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Stage 1: 2g curcumin (N = 22 participants due to 1 participant withdrew consent after start of treatment) Stage 2: 4g curcumin (N = 21 participants)

Reporting Groups
  Description
Curcumin

Stage 1: 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.

Stage 2: 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.

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

curcumin: Given orally


Baseline Measures
   Curcumin 
Overall Participants Analyzed 
[Units: Participants]
 43 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Stage1 2 g (curcumin) N=22   57.1  (5.0) 
Stage2 4 g (curcumin) N=21   52.2  (6.8) 
Gender, Customized 
[Units: Participants]
 
Stage1 2 g (curcumin): Female   13 
Stage1 2 g (curcumin): Male   9 
Stage2 4 g (curcumin): Female   12 
Stage2 4 g (curcumin): Male   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)   [ Time Frame: Baseline ]

2.  Primary:   Post-treatment in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)   [ Time Frame: At 30 day ]

3.  Secondary:   Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)   [ Time Frame: Baseline ]

4.  Secondary:   Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)   [ Time Frame: At 30 Day ]

5.  Secondary:   Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa   [ Time Frame: Baseline ]

6.  Secondary:   Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa   [ Time Frame: At 30 day ]

7.  Secondary:   Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa   [ Time Frame: Baseline ]

8.  Secondary:   Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa   [ Time Frame: At 30 day ]

9.  Secondary:   Change in Cyclooxygenases (COX-1, COX-2), and Lipoxygenase (5-LOX) Protein Abundance   [ Time Frame: Baseline to 30 days ]

10.  Secondary:   Changes in Total Aberrant Crypt Foci (ACF) Number   [ Time Frame: Baseline to 30 days ]

11.  Secondary:   Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third   [ Time Frame: Baseline ]

12.  Secondary:   Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third   [ Time Frame: At 30 day ]

13.  Secondary:   Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third   [ Time Frame: Baseline ]

14.  Secondary:   Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third   [ Time Frame: At 30 day ]

15.  Secondary:   Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third   [ Time Frame: Baseline ]

16.  Secondary:   Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third   [ Time Frame: At 30 day ]

17.  Secondary:   Baseline Curcumin Concentration in Rectal Mucosa   [ Time Frame: Baseline ]

18.  Secondary:   Post-treatment Curcumin Concentration in Rectal Mucosa   [ Time Frame: At 30 day ]

19.  Secondary:   Baseline Curcumin Plasma Concentrations   [ Time Frame: Baseline ]

20.  Secondary:   Post-treatment Curcumin Plasma Concentrations   [ Time Frame: At 30 day ]

21.  Secondary:   Baseline Curcumin Conjugates Concentration in Rectal Mucosa   [ Time Frame: Baseline ]

22.  Secondary:   Post-treatment Curcumin Conjugates Concentration in Rectal Mucosa   [ Time Frame: At 30 day ]

23.  Secondary:   Baseline Curcumin Conjugates Plasma Concentrations   [ Time Frame: Baseline ]

24.  Secondary:   Post-treatment Curcumin Conjugates Plasma Concentrations   [ Time Frame: At 30 day ]

25.  Secondary:   Number of Participants at Each Adverse Event Grade Level   [ Time Frame: Baseline to 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Frank L. Meyskens, Jr.
Organization: University of California, Irvine
phone: 714-456-6310
e-mail: flmeyske@uci.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00365209     History of Changes
Other Study ID Numbers: NCI-2013-00449
NCI-2013-00449 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UIC-2005-0617
CDR0000483003
UCIRVINE-2005-4586
UIC HS# 2005-0617
CCUM-HUM00000731
P30CA062203 ( U.S. NIH Grant/Contract )
2005-0617 ( Other Identifier: Chao Family Comprehensive Cancer Center )
UCI04-2-01 ( Other Identifier: DCP )
N01CN35160 ( U.S. NIH Grant/Contract )
Study First Received: August 16, 2006
Results First Received: April 18, 2014
Last Updated: July 30, 2015