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Curcumin in Treating Patients With Familial Adenomatous Polyposis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00641147
First Posted: March 24, 2008
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: July 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Familial Adenomatous Polyposis
Interventions: Drug: Curcumin
Other: Laboratory Biomarker Analysis
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were screened and enrolled at the Johns Hopkins Hospital and the University of Puerto Rico Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Curcumin)

Patients receive curcumin by mouth (PO) twice a day (BID) for 12 months.

Curcumin: Given PO

Arm II (Placebo)

Patients receive placebo PO BID for 12 months.

Placebo: Given PO


Participant Flow for 4 periods

Period 1:   Completed 4 Months.
    Arm I (Curcumin)   Arm II (Placebo)
STARTED   21   23 
COMPLETED   19   23 
NOT COMPLETED   2   0 
Physician Decision                1                0 
Adverse Event                1                0 

Period 2:   Completed 8 Months.
    Arm I (Curcumin)   Arm II (Placebo)
STARTED   19   23 
COMPLETED   16   21 
NOT COMPLETED   3   2 
Physician Decision                2                1 
non compliance                1                0 
Withdrawal by Subject                0                1 

Period 3:   Completed 12 Months.
    Arm I (Curcumin)   Arm II (Placebo)
STARTED   16   21 
COMPLETED   15   19 
NOT COMPLETED   1   2 
Physician Decision                1                1 
Withdrawal by Subject                0                1 

Period 4:   Completed 16 Months.
    Arm I (Curcumin)   Arm II (Placebo)
STARTED   15   19 
COMPLETED   13   19 
NOT COMPLETED   2   0 
Physician Decision                1                0 
Lost to Follow-up                1                0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Arm I (Curcumin)

Patients receive curcumin PO BID for 12 months.

Curcumin: Given PO

Arm II (Placebo)

Patients receive placebo PO BID for 12 months.

Placebo: Given PO

Total Total of all reporting groups

Baseline Measures
   Arm I (Curcumin)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   23   44 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.5  (15.4)   38.7  (15.0)   41.5  (15.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  66.7%      14  60.9%      28  63.6% 
Male      7  33.3%      9  39.1%      16  36.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      11  52.4%      11  47.8%      22  50.0% 
Not Hispanic or Latino      10  47.6%      12  52.2%      22  50.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1   4.3%      1   2.3% 
White      21 100.0%      22  95.7%      43  97.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Baseline number of polyps 
[Units: Polyps]
Mean (Standard Deviation)
 23.3  (19.7)   18.7  (13.1)   20.9  (16.6) 
Baseline size of polyps in mm 
[Units: Polyps]
Mean (Standard Deviation)
 3.1  (1.7)   2.3  (0.6)   2.6  (1.3) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Polyp Number   [ Time Frame: Up to 12 months ]

2.  Secondary:   Mean Polyp Size in mm   [ Time Frame: Up to 12 months ]

3.  Secondary:   Number of Participants With a Decrease in Polyp Burden at 12 Months   [ Time Frame: 12 months ]

4.  Secondary:   Number of Participants With Grade >=2 Adverse Events   [ Time Frame: Up to 12 months ]

5.  Secondary:   Medication Compliance   [ Time Frame: Up to 12 months ]

6.  Secondary:   Change in Ornithine Decarboxylase (ODC) Activity Levels   [ Time Frame: Baseline and 8 months ]

7.  Secondary:   Change in Total Polyamines Levels   [ Time Frame: Baseline and 8 months ]

8.  Secondary:   Change in Micro RNA 124-U6 (miR124-U6)   [ Time Frame: Baseline and 8 months ]

9.  Secondary:   Change in Spermidine/Spermine N-1 Acetyl Transferase (SSAT)   [ Time Frame: Baseline and 8 months ]

10.  Secondary:   Change in Spermine Oxidase (SMOX)   [ Time Frame: Baseline and 8months ]

11.  Secondary:   Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels   [ Time Frame: Baseline up to 8 months ]

12.  Secondary:   Change in Apoptosis Index Levels   [ Time Frame: 8 months ]

13.  Other Pre-specified:   Change in Mucosal DNA Methylation Levels.   [ Time Frame: Baseline to up to 12 months ]

14.  Other Pre-specified:   Change in Mucosal Leukotriene Levels.   [ Time Frame: Baseline to up to 12 months. ]

15.  Other Pre-specified:   Change in Mucosal Prostaglandin Levels.   [ Time Frame: Baseline to up to 12 months. ]

16.  Other Pre-specified:   Number of Patients Failing Study.   [ Time Frame: Up to 16 months. ]

17.  Other Pre-specified:   Change in Vascular Density   [ Time Frame: Baseline up to 12 months ]

18.  Other Pre-specified:   Activation of NFKB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) Pathway   [ Time Frame: Baseline to 12 months ]

19.  Other Pre-specified:   Change in Akt Phosphorylation Levels   [ Time Frame: Baseline up to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Study Coordinator
Organization: Johns Hopkins University
phone: 410-955-3817
e-mail: lhylind1@jhmi.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00641147     History of Changes
Other Study ID Numbers: NCI-2013-00536
NCI-2013-00536 ( Other Identifier: NCI )
CDR0000592794 ( Other Identifier: Clinical Trial Reporting Program )
NA_00011821 ( Other Identifier: Johns Hopkins University IRB )
1R01CA134620 ( U.S. NIH Grant/Contract )
R01CA134620 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
First Submitted: March 17, 2008
First Posted: March 24, 2008
Results First Submitted: July 13, 2017
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017