Curcumin in Treating Patients With Familial Adenomatous Polyposis

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00641147
• Collaborator: (none)
• Enrollment: 44
• Locations: 2
• Arms: 2
• Duration (Months): 74
• Patients Per Site: 22
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.

Condition or Disease	Intervention/Treatment	Phase
Familial Adenomatous Polyposis	Drug: Curcumin; Other: Laboratory Biomarker Analysis; Other: Placebo	Phase 2

Detailed Description

Specific Aims:

1. To determine in a randomized, double-blinded, placebo-controlled study the tolerability and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients with intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir) surgery.

2. To measure markers of cell proliferation including colorectal mucosal levels of ornithine decarboxylase (ODC), polyamines, mucosal deoxyribonucleic acid (DNA) methylation, proliferative index (Ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular density, mucosal prostaglandin, leukotriene levels, and activation of the nuclear factor kappa B (NFKB), and v-akt murine thymoma viral oncogene homolog 1 (Akt) survival pathways.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive curcumin orally (PO) twice daily (BID) for 12 months.

Arm II: Patients receive placebo PO BID for 12 months.

After completion of study treatment, patients are followed up at 4 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (curcumin) Patients receive curcumin PO BID for 12 months. Laboratory Biomarker Analysis	Drug: Curcumin; Given PO; Other Names: C.I. 75300 C.I. Natural Yellow 3 Diferuloylmethane Turmeric Yellow ; Other: Laboratory Biomarker Analysis; Correlative studies
Placebo Comparator: Arm II (placebo) Patients receive placebo PO BID for 12 months. Laboratory Biomarker Analysis	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Placebo; Given PO; Other Names: placebo therapy sham therapy

Outcome Measures

Primary Outcome Measures

1. Polyp Number [Up to 12 months]

   Average number of polyps in the placebo arm at the end of the study is compared to the average in the curcumin arm

Secondary Outcome Measures

1. Mean Polyp Size in mm [Up to 12 months]

   Mean size of the 5 largest polyps

2. Number of Participants With a Decrease in Polyp Burden at 12 Months [12 months]

   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.

3. Number of Participants With Grade >=2 Adverse Events [Up to 12 months]

   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.

4. Medication Compliance [Up to 12 months]

   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.

5. Change in Ornithine Decarboxylase (ODC) Activity Levels [Baseline and 8 months]

   Change in ODC mean activity levels (expressed as nmol of activity/mg of mucosal tissue/hr) at 8 months compared to baseline (time 0)

6. Change in Total Polyamines Levels [Baseline and 8 months]

   Polyamine mean level changes (expressed as pg/mg protein) at month 8-baseline

7. Change in Micro RNA 124-U6 (miR124-U6) [Baseline and 8 months]

   Change in MicroRNA mean activity level at 8 months compared to baseline (time 0)

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

   Change in SSAT mean activity level at 8 months compared to baseline (time 0)

9. Change in Spermine Oxidase (SMOX) [Baseline and 8months]

   Change in SMOX mean activity level at 8 months compared to baseline (time 0)

10. Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels [Baseline up to 8 months]

    Change in cellular proliferation rate was measured by assessment of Ki-67 anti-proliferative cell nuclear antibody index levels at 8 months

11. Change in Apoptosis Index Levels [8 months]

    Change in apoptosis index levels at 8 months by assessing cleaved Caspase-3 measurement

Other Outcome Measures

1. Change in Mucosal DNA Methylation Levels. [Baseline to up to 12 months]

2. Change in Mucosal Leukotriene Levels. [Baseline to up to 12 months.]

3. Change in Mucosal Prostaglandin Levels. [Baseline to up to 12 months.]

4. Number of Patients Failing Study. [Up to 16 months.]

   Patients withdrawn from study due to increasing polyp burden and/or advancing histology.

5. Change in Vascular Density [Baseline up to 12 months]

6. Activation of NFKB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) Pathway [Baseline to 12 months]

7. Change in Akt Phosphorylation Levels [Baseline up to 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir

• Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy

Exclusion Criteria:

• Female patients of childbearing age not on effective birth control

• Pregnant women

• White blood cell count (WBC) < 3500/ml

• Platelet count < 100,000/ml

• Blood urea nitrogen (BUN) > 25mg%

• Creatinine > 1.5mg%

• Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial

• Malignancy other than nonmelanoma skin cancer

• Active bacterial infection

• Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy)

• Patients with a history of peptic ulcer disease

• Patients on warfarin or plavix

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	United States	21287
2	University of Puerto Rico	San Juan		Puerto Rico	00936

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Francis Giardiello, Johns Hopkins University/Sidney Kimmel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00641147
• Other Study ID Numbers: NCI-2013-00536; NCI-2013-00536; CDR0000592794; NA_00011821; 1R01CA134620; R01CA134620; P30CA006973
• First Posted: Mar 24, 2008
• Last Update Posted: Sep 29, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli; Curcumin

Study Results

Participant Flow

Recruitment Details	Subjects were screened and enrolled at the Johns Hopkins Hospital and the University of Puerto Rico Hospital.

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
Period Title: Completed 4 Months.
STARTED	19	23
COMPLETED	16	21
NOT COMPLETED	3	2
Period Title: Completed 4 Months.
STARTED	16	21
COMPLETED	15	19
NOT COMPLETED	1	2
Period Title: Completed 4 Months.
STARTED	15	19
COMPLETED	13	19
NOT COMPLETED	2	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 Participants	21	23	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.5 (15.4)	38.7 (15.0)	41.5 (15.3)
Sex: Female, Male (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) (Count of Participants)
Hispanic or Latino	11 52.4%	11 47.8%	22 50%
Not Hispanic or Latino	10 47.6%	12 52.2%	22 50%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 4.3%	1 2.3%
White	21 100%	22 95.7%	43 97.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Baseline number of polyps (polyps) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [polyps]	23.3 (19.7)	18.7 (13.1)	20.9 (16.6)
Baseline size of polyps in mm (polyps) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [polyps]	3.1 (1.7)	2.3 (0.6)	2.6 (1.3)

Outcome Measures

1. Primary Outcome

Title	Polyp Number
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	16	21
Mean (95% Confidence Interval) [polyps]	22.6	18.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.57
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Mean Polyp Size in mm
Description	Mean size of the 5 largest polyps
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	16	21
Mean (95% Confidence Interval) [mm]	2.3	2.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.76
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Number of Participants With a Decrease in Polyp Burden at 12 Months
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	15	19
Count of Participants [Participants]	4 19%	6 26.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Number of Participants With Grade >=2 Adverse Events
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	21	23
Count of Participants [Participants]	6 28.6%	2 8.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Medication Compliance
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	19	23
Median (Full Range) [percentage of total compliance]	0.83	0.91

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Change in Ornithine Decarboxylase (ODC) Activity Levels
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	21	23
Mean (Standard Deviation) [nmol/mg/hr]	1.19 (0.71)	0.88 (1.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Change in Total Polyamines Levels
Description	Polyamine mean level changes (expressed as pg/mg protein) at month 8-baseline
Time Frame	Baseline and 8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	21	23
Mean (Standard Deviation) [pg/mg protein]	0.23 (3.41)	1.66 (3.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Change in Micro RNA 124-U6 (miR124-U6)
Description	Change in MicroRNA mean activity level at 8 months compared to baseline (time 0)
Time Frame	Baseline and 8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	21	23
Mean (Standard Deviation) [qRT-PCR relative to U6 snRNA]	1.44 (1.08)	4.88 (11.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments
	Method	t-test, 2 sided
	Comments

9. Secondary Outcome

Title	Change in Spermidine/Spermine N-1 Acetyl Transferase (SSAT)
Description	Change in SSAT mean activity level at 8 months compared to baseline (time 0)
Time Frame	Baseline and 8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	21	23
Mean (Standard Deviation) [pmol/acetylspermidine/mg protein/min]	0.97 (0.51)	0.99 (0.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	t-test, 2 sided
	Comments

10. Secondary Outcome

Title	Change in Spermine Oxidase (SMOX)
Description	Change in SMOX mean activity level at 8 months compared to baseline (time 0)
Time Frame	Baseline and 8months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	21	23
Mean (Standard Deviation) [pmol H2O2 per min per mg protein]	1.20 (0.57)	1.56 (2.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

Title	Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels
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

Outcome Measure Data

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)
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
Measure Participants	7	10
Mean (Standard Deviation) [labeled cells/crypt epithelial cells]	0.47 (0.21)	0.41 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	t-test, 2 sided
	Comments

12. Secondary Outcome

Title	Change in Apoptosis Index Levels
Description	Change in apoptosis index levels at 8 months by assessing cleaved Caspase-3 measurement
Time Frame	8 months

Outcome Measure Data

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)
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
Measure Participants	7	10
Mean (Standard Deviation) [apoptotic rate]	0.57 (0.98)	2.44 (2.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	t-test, 2 sided
	Comments

13. Other Pre-specified Outcome

Title	Change in Mucosal DNA Methylation Levels.
Time Frame	Baseline to up to 12 months

Outcome Measure Data

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)
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
Measure Participants	0	0

14. Other Pre-specified Outcome

Title	Change in Mucosal Leukotriene Levels.
Time Frame	Baseline to up to 12 months.

Outcome Measure Data

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)
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
Measure Participants	0	0

15. Other Pre-specified Outcome

Title	Change in Mucosal Prostaglandin Levels.
Time Frame	Baseline to up to 12 months.

Outcome Measure Data

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)
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
Measure Participants	0	0

16. Other Pre-specified Outcome

Title	Number of Patients Failing Study.
Description	Patients withdrawn from study due to increasing polyp burden and/or advancing histology.
Time Frame	Up to 16 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Curcumin)	Arm II (Placebo)
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
Measure Participants	21	23
Count of Participants [Participants]	1 4.8%	1 4.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments
	Method	Chi-squared
	Comments

17. Other Pre-specified Outcome

Title	Change in Vascular Density
Time Frame	Baseline up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

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
Measure Participants	0	0

18. Other Pre-specified Outcome

Title	Activation of NFKB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) Pathway
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

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
Measure Participants	0	0

19. Other Pre-specified Outcome

Title	Change in Akt Phosphorylation Levels
Time Frame	Baseline up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

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
Measure Participants	0	0

Adverse Events

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)
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/23 (0%)
Serious Adverse Events
	Arm I (Curcumin)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/21 (14.3%)		1/23 (4.3%)
Gastrointestinal disorders
Abdominal pain	2/21 (9.5%)	2	0/23 (0%)	0
Psychiatric disorders
Depression	0/21 (0%)	0	1/23 (4.3%)	1
Skin and subcutaneous tissue disorders
Facial abscess	1/21 (4.8%)	1	0/23 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm I (Curcumin)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/21 (38.1%)		13/23 (56.5%)
Blood and lymphatic system disorders
Iron deficiency anemia	1/21 (4.8%)	1	1/23 (4.3%)	1
Gastrointestinal disorders
Abdominal pain	3/21 (14.3%)	5	3/23 (13%)	3
Diarrhea	2/21 (9.5%)	2	2/23 (8.7%)	2
Nausea	0/21 (0%)	0	1/23 (4.3%)	1
Infections and infestations
Facial abscess	1/21 (4.8%)	1	0/23 (0%)	0
Influenza	0/21 (0%)	0	1/23 (4.3%)	1
Viral infection	0/21 (0%)	0	1/23 (4.3%)	1
Metabolism and nutrition disorders
Gout	1/21 (4.8%)	1	0/23 (0%)	0
Musculoskeletal and connective tissue disorders
Back strain	1/21 (4.8%)	1	0/23 (0%)	0
Plantar fascilitis	0/21 (0%)	0	1/23 (4.3%)	1
Torn ligament	0/21 (0%)	0	1/23 (4.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer	1/21 (4.8%)	1	1/23 (4.3%)	1
Psychiatric disorders
Depression	0/21 (0%)	0	1/23 (4.3%)	1
Renal and urinary disorders
Urinary tract infection	1/21 (4.8%)	1	0/23 (0%)	0
Respiratory, thoracic and mediastinal disorders
Sinusitis	0/21 (0%)	0	1/23 (4.3%)	1
Upper respiratory infection	1/21 (4.8%)	1	0/23 (0%)	0
Skin and subcutaneous tissue disorders
Pruritus	1/21 (4.8%)	1	0/23 (0%)	0
Cellulitis	0/21 (0%)	0	1/23 (4.3%)	1
Herpes Zoster	0/21 (0%)	0	1/23 (4.3%)	1
Vascular disorders
Headache migraine	0/21 (0%)	0	1/23 (4.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.