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Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

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ClinicalTrials.gov Identifier: NCT00927485
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Marcia R. Cruz-Correa, MD, PhD, University of Puerto Rico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Familial Adenomatous Polyposis
Interventions Drug: Calcumin (Curcumin)
Other: Risk Factor Questionnaire
Other: Blood samples
Other: Biopsies (Sigmoidoscopy)
Other: Biopsies (Upper endoscopy)
Enrollment 44
Recruitment Details The study was conducted from September 2011 to November 2016 at the Johns Hopkins Hospital and the University of Puerto Rico Medical Sciences Campus. Participants were identified and recruited from the Johns Hopkins Polyposis Registry or from the University of Puerto Rico Familial Colorectal Cancer Registry.
Pre-assignment Details Absence of effective birth control; pregnancy; WBC < 3500/ml; platelet < 100,000/ml, BUN > 25 mg/dl, Creat > 1.5 mg/dl; malignancy; unwillingness to discontinue NSAIDs; active reflux; hx of peptic ulcer; active bacterial infection; use of warfarin or antiplatelets; allergy to curcumin. 3 month washout period for individuals taking NSAIDs, curcumin, turmeric, aspirin, calcium, vitamin D, green tea or polyphenol E
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description

Curcumin

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Placebo (sugar pills)

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Period Title: Overall Study
Started 21 23
Completed 15 19
Not Completed 6 4
Reason Not Completed
Adverse Event             4             2
noncompliance, prophylactic surgery, inc             2             2
Arm/Group Title Curcumin Placebo Total
Hide Arm/Group Description

Curcumin

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Placebo (sugar pills)

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Total of all reporting groups
Overall Number of Baseline Participants 21 23 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
23
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 23 participants 44 participants
44.5  (1) 38.7  (1) 41.6  (1)
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%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Puerto Rico Number Analyzed 21 participants 23 participants 44 participants
21 23 44
1.Primary Outcome
Title Number of Polyps
Hide Description To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number in patients with FAP.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description:

Curcumin

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Placebo (sugar pills)

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Overall Number of Participants Analyzed 21 23
Mean (95% Confidence Interval)
Unit of Measure: Number of Polyps
18.6
(12.1 to 33.1)
22.6
(9.93 to 27.8)
2.Primary Outcome
Title Size of Polyps
Hide Description To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp size in patients with FAP.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description:

Curcumin

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Placebo (sugar pills)

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Overall Number of Participants Analyzed 21 23
Mean (95% Confidence Interval)
Unit of Measure: mm
2.3
(1.8 to 2.8)
2.1
(1.5 to 2.7)
Time Frame Five Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description

Curcumin

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Placebo (sugar pills)

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

All-Cause Mortality
Curcumin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Curcumin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/23 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Curcumin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/21 (23.81%)      5/23 (21.74%)    
Gastrointestinal disorders     
Abdominal Pain   3/21 (14.29%)  3 3/23 (13.04%)  3
Diarrhea   2/21 (9.52%)  2 2/23 (8.70%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Marcia Cruz-Correa
Organization: University of Puerto Rico Medical Sciences Campus
Phone: 787-758-2525 ext 1722
EMail: marcia.cruz1@upr.edu
Layout table for additonal information
Responsible Party: Marcia R. Cruz-Correa, MD, PhD, University of Puerto Rico
ClinicalTrials.gov Identifier: NCT00927485    
Other Study ID Numbers: Protocol A2210108-UPR
First Submitted: June 24, 2009
First Posted: June 25, 2009
Results First Submitted: November 18, 2020
Results First Posted: December 16, 2020
Last Update Posted: December 16, 2020