Trial Outcomes & Findings for Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP) (NCT NCT00927485)
NCT ID: NCT00927485
Last Updated: 2020-12-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
5 years
Results posted on
2020-12-16
Participant Flow
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.
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
Participant milestones
| Measure |
Curcumin
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
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 Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Curcumin
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
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 Study
Adverse Event
|
4
|
2
|
|
Overall Study
noncompliance, prophylactic surgery, inc
|
2
|
2
|
Baseline Characteristics
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Baseline characteristics by cohort
| Measure |
Curcumin
n=21 Participants
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
n=23 Participants
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
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
44.5 Years
STANDARD_DEVIATION 1 • n=93 Participants
|
38.7 Years
STANDARD_DEVIATION 1 • n=4 Participants
|
41.6 Years
STANDARD_DEVIATION 1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
Puerto Rico
|
21 participants
n=93 Participants
|
23 participants
n=4 Participants
|
44 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 5 yearsTo 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.
Outcome measures
| Measure |
Curcumin
n=21 Participants
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
n=23 Participants
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.
|
|---|---|---|
|
Number of Polyps
|
18.6 Number of Polyps
Interval 12.1 to 33.1
|
22.6 Number of Polyps
Interval 9.93 to 27.8
|
PRIMARY outcome
Timeframe: 5 yearsTo 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.
Outcome measures
| Measure |
Curcumin
n=21 Participants
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
n=23 Participants
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.
|
|---|---|---|
|
Size of Polyps
|
2.3 mm
Interval 1.8 to 2.8
|
2.1 mm
Interval 1.5 to 2.7
|
Adverse Events
Curcumin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Curcumin
n=21 participants at risk
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
n=23 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
3/21 • Number of events 3 • Five Years
|
13.0%
3/23 • Number of events 3 • Five Years
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
2/21 • Number of events 2 • Five Years
|
8.7%
2/23 • Number of events 2 • Five Years
|
Additional Information
Dr. Marcia Cruz-Correa
University of Puerto Rico Medical Sciences Campus
Phone: 787-758-2525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place