Trial record 3 of 3 for:
curcumin, turmeric | Completed Studies | Studies With Results | Interventional Studies | cancer
Curcumin in Treating Patients With Familial Adenomatous Polyposis
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| ClinicalTrials.gov Identifier: NCT00641147 |
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Recruitment Status :
Completed
First Posted : March 24, 2008
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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| 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 |
| Enrollment | 44 |
Participant Flow
| Recruitment Details | Subjects were screened and enrolled at the Johns Hopkins Hospital and the University of Puerto Rico Hospital. |
| Pre-assignment Details |
| Arm/Group Title | Arm I (Curcumin) | Arm II (Placebo) |
|---|---|---|
 Arm/Group Description |
Patients receive curcumin by mouth (PO) twice a day (BID) for 12 months. Curcumin: Given PO |
Patients receive placebo PO BID for 12 months. Placebo: Given PO |
| Period Title: Completed 4 Months. | ||
| Started | 21 | 23 |
| Completed | 19 | 23 |
| Not Completed | 2 | 0 |
| Reason Not Completed | ||
| Physician Decision | 1 | 0 |
| Adverse Event | 1 | 0 |
| Period Title: Completed 8 Months. | ||
| Started | 19 | 23 |
| Completed | 16 | 21 |
| Not Completed | 3 | 2 |
| Reason Not Completed | ||
| Physician Decision | 2 | 1 |
| non compliance | 1 | 0 |
| Withdrawal by Subject | 0 | 1 |
| Period Title: Completed 12 Months. | ||
| Started | 16 | 21 |
| Completed | 15 | 19 |
| Not Completed | 1 | 2 |
| Reason Not Completed | ||
| Physician Decision | 1 | 1 |
| Withdrawal by Subject | 0 | 1 |
| Period Title: Completed 16 Months. | ||
| Started | 15 | 19 |
| Completed | 13 | 19 |
| Not Completed | 2 | 0 |
| Reason Not Completed | ||
| Physician Decision | 1 | 0 |
| Lost to Follow-up | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Arm I (Curcumin) | Arm II (Placebo) | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Patients receive curcumin PO BID for 12 months. Curcumin: Given PO |
Patients receive placebo PO BID for 12 months. Placebo: Given PO |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 21 | 23 | 44 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 21 participants | 23 participants | 44 participants | |
| 44.5 (15.4) | 38.7 (15.0) | 41.5 (15.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 21 participants | 23 participants | 44 participants | |
| Female |
14 66.7%
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14 60.9%
|
28 63.6%
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| Male |
7 33.3%
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9 39.1%
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16 36.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 21 participants | 23 participants | 44 participants | |
| Hispanic or Latino |
11 52.4%
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11 47.8%
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22 50.0%
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| Not Hispanic or Latino |
10 47.6%
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12 52.2%
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22 50.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 21 participants | 23 participants | 44 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
0 0.0%
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0 0.0%
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0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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1 4.3%
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1 2.3%
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| White |
21 100.0%
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22 95.7%
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43 97.7%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Baseline number of polyps
Mean (Standard Deviation) Unit of measure: Polyps |
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| Number Analyzed | 21 participants | 23 participants | 44 participants | |
| 23.3 (19.7) | 18.7 (13.1) | 20.9 (16.6) | ||
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Baseline size of polyps in mm
Mean (Standard Deviation) Unit of measure: Polyps |
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| Number Analyzed | 21 participants | 23 participants | 44 participants | |
| 3.1 (1.7) | 2.3 (0.6) | 2.6 (1.3) | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Study Coordinator |
| Organization: | Johns Hopkins University |
| Phone: | 410-955-3817 |
| EMail: | lhylind1@jhmi.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00641147 |
| 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 |