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Trial record 95 of 167 for:    curcumin

Curcumin in Treating Patients With Familial Adenomatous Polyposis

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.
 
ClinicalTrials.gov Identifier: NCT00641147
Recruitment Status : Completed
First Posted : March 24, 2008
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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
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)
Hide 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
Arm/Group Title Arm I (Curcumin) Arm II (Placebo) Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 23 participants 44 participants
44.5  (15.4) 38.7  (15.0) 41.5  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
Female
14
  66.7%
14
  60.9%
28
  63.6%
Male
7
  33.3%
9
  39.1%
16
  36.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 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  
Mean (Standard Deviation)
Unit of measure:  Polyps
Number Analyzed 21 participants 23 participants 44 participants
23.3  (19.7) 18.7  (13.1) 20.9  (16.6)
Baseline size of polyps in mm  
Mean (Standard Deviation)
Unit of measure:  Polyps
Number Analyzed 21 participants 23 participants 44 participants
3.1  (1.7) 2.3  (0.6) 2.6  (1.3)
1.Primary Outcome
Title Polyp Number
Hide Description Average number of polyps in the placebo arm at the end of the study is compared to the average in the curcumin arm
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive curcumin 3.0 grams PO BID for 12 months.

Curcumin: Given PO

Patients receive placebo PO BID for 12 months.

Placebo: Given PO

Overall Number of Participants Analyzed 16 21
Mean (95% Confidence Interval)
Unit of Measure: polyps
22.6
(12.1 to 33.1)
18.6
(9.3 to 27.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Mean Polyp Size in mm
Hide Description Mean size of the 5 largest polyps
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive curcumin 3.0 grams PO BID for 12 months.

Curcumin: Given PO

Patients receive placebo PO BID for 12 months.

Placebo: Given PO

Overall Number of Participants Analyzed 16 21
Mean (95% Confidence Interval)
Unit of Measure: mm
2.3
(1.6 to 3.0)
2.1
(1.5 to 2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With a Decrease in Polyp Burden at 12 Months
Hide Description The polyp burden as evaluated by video tape review. Polyp burden at 12 months compared to time 0 for each participant and counting participants with decrease in polyp burden at 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 15 19
Measure Type: Count of Participants
Unit of Measure: Participants
4
  26.7%
6
  31.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Grade >=2 Adverse Events
Hide Description

Events were graded as follows:

Grade 0= no adverse event or within normal limits; Grade 1= mild adverse event (causing no limitations of usual activity); Grade 2= moderate adverse event (causing some limitation of activity); Grade 3= severe adverse event (severe and undesirable; causing inability to carry out usual activities; Grade 4= life threatening or disabling adverse event; Grade 5= fatal adverse event.

Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive curcumin 3.0 grams PO BID for 12 months.

Curcumin: Given PO

Patients receive placebo PO BID for 12 months.

Placebo: Given PO

Overall Number of Participants Analyzed 21 23
Measure Type: Count of Participants
Unit of Measure: Participants
6
  28.6%
2
   8.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Medication Compliance
Hide Description Medication compliance of the participant= number of capsules taken divided by the number of capsules prescribed as determined by pill count and described as a percentage per participant. Then the compliance of each participant in the assigned group (curcumin or placebo) was averaged together to obtain the medication compliance rate of that group.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 19 23
Median (Full Range)
Unit of Measure: percentage of total compliance
0.83
(0.70 to 0.94)
0.91
(0.78 to 0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change in Ornithine Decarboxylase (ODC) Activity Levels
Hide Description Change in ODC mean activity levels (expressed as nmol of activity/mg of mucosal tissue/hr) at 8 months compared to baseline (time 0)
Time Frame Baseline and 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: nmol/mg/hr
1.19  (0.71) 0.88  (1.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Change in Total Polyamines Levels
Hide Description Polyamine mean level changes (expressed as pg/mg protein) at month 8-baseline
Time Frame Baseline and 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive curcumin PO BID for 12 months.

Curcumin: Given PO

Laboratory Biomarker Analysis: Correlative studies

Patients receive placebo PO BID for 12 months.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: pg/mg protein
0.23  (3.41) 1.66  (3.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change in Micro RNA 124-U6 (miR124-U6)
Hide Description Change in MicroRNA mean activity level at 8 months compared to baseline (time 0)
Time Frame Baseline and 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: qRT-PCR relative to U6 snRNA
1.44  (1.08) 4.88  (11.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change in Spermidine/Spermine N-1 Acetyl Transferase (SSAT)
Hide Description Change in SSAT mean activity level at 8 months compared to baseline (time 0)
Time Frame Baseline and 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: pmol/acetylspermidine/mg protein/min
0.97  (0.51) 0.99  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Change in Spermine Oxidase (SMOX)
Hide Description Change in SMOX mean activity level at 8 months compared to baseline (time 0)
Time Frame Baseline and 8months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: pmol H2O2 per min per mg protein
1.20  (0.57) 1.56  (2.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels
Hide Description Change in cellular proliferation rate was measured by assessment of Ki-67 anti-proliferative cell nuclear antibody index levels at 8 months
Time Frame Baseline up to 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
Specimens for analysis were only available on 7 curcumin and 10 placebo participants.
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 7 10
Mean (Standard Deviation)
Unit of Measure: labeled cells/crypt epithelial cells
0.47  (0.21) 0.41  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Change in Apoptosis Index Levels
Hide Description Change in apoptosis index levels at 8 months by assessing cleaved Caspase-3 measurement
Time Frame 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
Specimens for analysis were only available on 7 curcumin and 10 placebo participants.
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 7 10
Mean (Standard Deviation)
Unit of Measure: apoptotic rate
0.57  (0.98) 2.44  (2.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Other Pre-specified Outcome
Title Change in Mucosal DNA Methylation Levels.
Hide Description [Not Specified]
Time Frame Baseline to up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome data were not collected and the outcome will never be analyzed.
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Other Pre-specified Outcome
Title Change in Mucosal Leukotriene Levels.
Hide Description [Not Specified]
Time Frame Baseline to up to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome data were not collected and the outcome will never be analyzed.
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Other Pre-specified Outcome
Title Change in Mucosal Prostaglandin Levels.
Hide Description [Not Specified]
Time Frame Baseline to up to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome data were not collected and the outcome will never be analyzed.
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Other Pre-specified Outcome
Title Number of Patients Failing Study.
Hide Description Patients withdrawn from study due to increasing polyp burden and/or advancing histology.
Time Frame Up to 16 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 21 23
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.8%
1
   4.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Curcumin), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
17.Other Pre-specified Outcome
Title Change in Vascular Density
Hide Description [Not Specified]
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Other Pre-specified Outcome
Title Activation of NFKB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) Pathway
Hide Description [Not Specified]
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Other Pre-specified Outcome
Title Change in Akt Phosphorylation Levels
Hide Description [Not Specified]
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Reported adverse events (AE) included events starting on or after day 0 and on or before month 16.
Adverse Event Reporting Description If a subject experienced more than 1 of a given AE the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class the subject is only counted once.
 
Arm/Group Title Arm I (Curcumin) Arm II (Placebo)
Hide 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

All-Cause Mortality
Arm I (Curcumin) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Curcumin) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/21 (14.29%)      1/23 (4.35%)    
Gastrointestinal disorders     
Abdominal pain * [1]  2/21 (9.52%)  2 0/23 (0.00%)  0
Psychiatric disorders     
Depression *  0/21 (0.00%)  0 1/23 (4.35%)  1
Skin and subcutaneous tissue disorders     
Facial abscess *  1/21 (4.76%)  1 0/23 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Subject developed appendicitis unrelated to study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Curcumin) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/21 (38.10%)      13/23 (56.52%)    
Blood and lymphatic system disorders     
Iron deficiency anemia *  1/21 (4.76%)  1 1/23 (4.35%)  1
Gastrointestinal disorders     
Abdominal pain *  3/21 (14.29%)  5 3/23 (13.04%)  3
Diarrhea *  2/21 (9.52%)  2 2/23 (8.70%)  2
Nausea *  0/21 (0.00%)  0 1/23 (4.35%)  1
Infections and infestations     
Facial abscess *  1/21 (4.76%)  1 0/23 (0.00%)  0
Influenza *  0/21 (0.00%)  0 1/23 (4.35%)  1
Viral infection *  0/21 (0.00%)  0 1/23 (4.35%)  1
Metabolism and nutrition disorders     
Gout *  1/21 (4.76%)  1 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back strain *  1/21 (4.76%)  1 0/23 (0.00%)  0
Plantar fascilitis *  0/21 (0.00%)  0 1/23 (4.35%)  1
Torn ligament *  0/21 (0.00%)  0 1/23 (4.35%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thyroid Cancer *  1/21 (4.76%)  1 1/23 (4.35%)  1
Psychiatric disorders     
Depression *  0/21 (0.00%)  0 1/23 (4.35%)  1
Renal and urinary disorders     
Urinary tract infection *  1/21 (4.76%)  1 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Sinusitis *  0/21 (0.00%)  0 1/23 (4.35%)  1
Upper respiratory infection *  1/21 (4.76%)  1 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus *  1/21 (4.76%)  1 0/23 (0.00%)  0
Cellulitis *  0/21 (0.00%)  0 1/23 (4.35%)  1
Herpes Zoster *  0/21 (0.00%)  0 1/23 (4.35%)  1
Vascular disorders     
Headache migraine *  0/21 (0.00%)  0 1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Coordinator
Organization: Johns Hopkins University
Phone: 410-955-3817
EMail: lhylind1@jhmi.edu
Layout table for additonal information
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