Trial Outcomes & Findings for ASPirin Intervention for the REDuction of Colorectal Cancer Risk (NCT NCT02394769)
NCT ID: NCT02394769
Last Updated: 2025-12-04
Results Overview
Measured using liquid chromatography/mass spectrometry
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
8-12 weeks
Results posted on
2025-12-04
Participant Flow
Patients who meet the inclusion criteria will be identified through investigators during their routine clinical practice, supplemented by a periodic query of the MGH endoscopy and pathology databases. Potentially eligible participants are approached by letter from their treating physician. Two weeks after receiving the letter, study staff will contact eligible parties and screen for eligibility via phone interview. Enrollment began in July 2015 and ended in February 2019.
Participant milestones
| Measure |
Placebo (For Aspirin)
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.
Placebo for Aspirin
|
Low Dose Aspirin
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.
Aspirin
|
Standard Dose Aspirin
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.
Aspirin
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
58
|
57
|
54
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Menopausal status of female participants, only
Baseline characteristics by cohort
| Measure |
Placebo (For Aspirin)
n=60 Participants
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.
Placebo for Aspirin
|
Low Dose Aspirin
n=60 Participants
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.
Aspirin
|
Standard Dose Aspirin
n=60 Participants
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.
Aspirin
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Menopause status
Postmenopausal
|
20 participants
n=28 Participants • Menopausal status of female participants, only
|
17 participants
n=29 Participants • Menopausal status of female participants, only
|
18 participants
n=28 Participants • Menopausal status of female participants, only
|
55 participants
n=85 Participants • Menopausal status of female participants, only
|
|
Menopause status
Missing
|
1 participants
n=28 Participants • Menopausal status of female participants, only
|
2 participants
n=29 Participants • Menopausal status of female participants, only
|
3 participants
n=28 Participants • Menopausal status of female participants, only
|
6 participants
n=85 Participants • Menopausal status of female participants, only
|
|
Statin use
Missing
|
2 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=180 Participants
|
|
Menopause status
Perimenopausal
|
4 participants
n=28 Participants • Menopausal status of female participants, only
|
1 participants
n=29 Participants • Menopausal status of female participants, only
|
2 participants
n=28 Participants • Menopausal status of female participants, only
|
7 participants
n=85 Participants • Menopausal status of female participants, only
|
|
Marital status
Never married
|
6 Participants
n=60 Participants
|
12 Participants
n=60 Participants
|
11 Participants
n=60 Participants
|
29 Participants
n=180 Participants
|
|
Marital status
Separated
|
2 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=180 Participants
|
|
Marital status
Divorced
|
8 Participants
n=60 Participants
|
7 Participants
n=60 Participants
|
7 Participants
n=60 Participants
|
22 Participants
n=180 Participants
|
|
Marital status
Widowed
|
4 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
4 Participants
n=60 Participants
|
10 Participants
n=180 Participants
|
|
Body Mass Index
|
26.8 kg/m2
STANDARD_DEVIATION 5.0 • n=60 Participants
|
28.4 kg/m2
STANDARD_DEVIATION 4.9 • n=60 Participants
|
27.5 kg/m2
STANDARD_DEVIATION 5.7 • n=60 Participants
|
27.6 kg/m2
STANDARD_DEVIATION 5.2 • n=180 Participants
|
|
Body Mass Index, categories
Normal, <18.5-24.9
|
21 Participants
n=60 Participants
|
16 Participants
n=60 Participants
|
21 Participants
n=60 Participants
|
58 Participants
n=180 Participants
|
|
Body Mass Index, categories
Overweight, 25.0-29.9
|
26 Participants
n=60 Participants
|
26 Participants
n=60 Participants
|
23 Participants
n=60 Participants
|
75 Participants
n=180 Participants
|
|
Body Mass Index, categories
Obese ≥30.0
|
13 Participants
n=60 Participants
|
18 Participants
n=60 Participants
|
16 Participants
n=60 Participants
|
47 Participants
n=180 Participants
|
|
Smoking status
Never
|
38 Participants
n=60 Participants
|
36 Participants
n=60 Participants
|
32 Participants
n=60 Participants
|
106 Participants
n=180 Participants
|
|
Smoking status
Former
|
18 Participants
n=60 Participants
|
20 Participants
n=60 Participants
|
19 Participants
n=60 Participants
|
57 Participants
n=180 Participants
|
|
Smoking status
Current
|
4 Participants
n=60 Participants
|
3 Participants
n=60 Participants
|
8 Participants
n=60 Participants
|
15 Participants
n=180 Participants
|
|
Smoking status
Missing
|
0 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=180 Participants
|
|
Alcohol consumption
Never
|
7 Participants
n=60 Participants
|
11 Participants
n=60 Participants
|
11 Participants
n=60 Participants
|
29 Participants
n=180 Participants
|
|
Alcohol consumption
Rarely
|
14 Participants
n=60 Participants
|
16 Participants
n=60 Participants
|
18 Participants
n=60 Participants
|
48 Participants
n=180 Participants
|
|
Alcohol consumption
1-5 times/week
|
29 Participants
n=60 Participants
|
24 Participants
n=60 Participants
|
23 Participants
n=60 Participants
|
76 Participants
n=180 Participants
|
|
Alcohol consumption
Daily
|
10 Participants
n=60 Participants
|
8 Participants
n=60 Participants
|
6 Participants
n=60 Participants
|
24 Participants
n=180 Participants
|
|
Alcohol consumption
More than daily
|
0 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
3 Participants
n=180 Participants
|
|
Personal cancer history, yes
|
10 Participants
n=60 Participants
|
6 Participants
n=60 Participants
|
4 Participants
n=60 Participants
|
20 Participants
n=180 Participants
|
|
Family history of colorectal cancer, yes
|
13 Participants
n=60 Participants
|
10 Participants
n=60 Participants
|
12 Participants
n=60 Participants
|
35 Participants
n=180 Participants
|
|
Type II diabetes, yes
|
2 Participants
n=60 Participants
|
3 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
7 Participants
n=180 Participants
|
|
Menopause status
Premenopausal
|
3 participants
n=28 Participants • Menopausal status of female participants, only
|
9 participants
n=29 Participants • Menopausal status of female participants, only
|
5 participants
n=28 Participants • Menopausal status of female participants, only
|
17 participants
n=85 Participants • Menopausal status of female participants, only
|
|
Race (NIH/OMB)
White
|
55 Participants
n=60 Participants
|
52 Participants
n=60 Participants
|
53 Participants
n=60 Participants
|
160 Participants
n=180 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
4 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
6 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=180 Participants
|
|
Marital status
Married
|
40 Participants
n=60 Participants
|
39 Participants
n=60 Participants
|
37 Participants
n=60 Participants
|
116 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
3 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=60 Participants
|
4 Participants
n=60 Participants
|
3 Participants
n=60 Participants
|
10 Participants
n=180 Participants
|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 9.2 • n=60 Participants
|
56.1 years
STANDARD_DEVIATION 8.7 • n=60 Participants
|
57.5 years
STANDARD_DEVIATION 8.3 • n=60 Participants
|
56.9 years
STANDARD_DEVIATION 8.7 • n=180 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=60 Participants
|
29 Participants
n=60 Participants
|
28 Participants
n=60 Participants
|
85 Participants
n=180 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=60 Participants
|
31 Participants
n=60 Participants
|
32 Participants
n=60 Participants
|
95 Participants
n=180 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
5 Participants
n=180 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=60 Participants
|
58 Participants
n=60 Participants
|
59 Participants
n=60 Participants
|
175 Participants
n=180 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=180 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=180 Participants
|
|
History of 81 mg aspirin use
Never
|
55 Participants
n=60 Participants
|
50 Participants
n=60 Participants
|
53 Participants
n=60 Participants
|
158 Participants
n=180 Participants
|
|
History of 81 mg aspirin use
Intermittently (<2x/week)
|
2 Participants
n=60 Participants
|
5 Participants
n=60 Participants
|
5 Participants
n=60 Participants
|
12 Participants
n=180 Participants
|
|
History of 81 mg aspirin use
Regularly (>2x/week)
|
2 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
6 Participants
n=180 Participants
|
|
History of 81 mg aspirin use
Missing
|
1 Participants
n=60 Participants
|
3 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
4 Participants
n=180 Participants
|
|
History of 325 mg aspirin use
Never
|
40 Participants
n=60 Participants
|
42 Participants
n=60 Participants
|
42 Participants
n=60 Participants
|
124 Participants
n=180 Participants
|
|
History of 325 mg aspirin use
Intermittently (<2x/week)
|
17 Participants
n=60 Participants
|
15 Participants
n=60 Participants
|
17 Participants
n=60 Participants
|
49 Participants
n=180 Participants
|
|
History of 325 mg aspirin use
Regularly (>2x/week)
|
1 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=180 Participants
|
|
History of 325 mg aspirin use
Missing
|
2 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
4 Participants
n=180 Participants
|
|
History of non-steroidal anti-inflammatory drug use
Never
|
18 Participants
n=60 Participants
|
13 Participants
n=60 Participants
|
19 Participants
n=60 Participants
|
50 Participants
n=180 Participants
|
|
History of non-steroidal anti-inflammatory drug use
Intermittently (<2x/week)
|
31 Participants
n=60 Participants
|
36 Participants
n=60 Participants
|
32 Participants
n=60 Participants
|
99 Participants
n=180 Participants
|
|
History of non-steroidal anti-inflammatory drug use
Regularly (>2x/week)
|
10 Participants
n=60 Participants
|
9 Participants
n=60 Participants
|
8 Participants
n=60 Participants
|
27 Participants
n=180 Participants
|
|
History of non-steroidal anti-inflammatory drug use
Missing
|
1 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=180 Participants
|
|
Proton pump inhibitor use
Current and regular
|
5 Participants
n=60 Participants
|
6 Participants
n=60 Participants
|
8 Participants
n=60 Participants
|
19 Participants
n=180 Participants
|
|
Proton pump inhibitor use
No, never regularly
|
48 Participants
n=60 Participants
|
49 Participants
n=60 Participants
|
48 Participants
n=60 Participants
|
145 Participants
n=180 Participants
|
|
Proton pump inhibitor use
Missing
|
7 Participants
n=60 Participants
|
5 Participants
n=60 Participants
|
4 Participants
n=60 Participants
|
16 Participants
n=180 Participants
|
|
H2-blocker use
Current and regular
|
2 Participants
n=60 Participants
|
5 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
9 Participants
n=180 Participants
|
|
H2-blocker use
No, never regularly
|
56 Participants
n=60 Participants
|
54 Participants
n=60 Participants
|
57 Participants
n=60 Participants
|
167 Participants
n=180 Participants
|
|
H2-blocker use
Missing
|
2 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=180 Participants
|
|
Antacid use
Current and regular
|
5 Participants
n=60 Participants
|
3 Participants
n=60 Participants
|
3 Participants
n=60 Participants
|
11 Participants
n=180 Participants
|
|
Antacid use
No, never regularly
|
54 Participants
n=60 Participants
|
57 Participants
n=60 Participants
|
57 Participants
n=60 Participants
|
168 Participants
n=180 Participants
|
|
Antacid use
Missing
|
1 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=180 Participants
|
|
Statin use
Current and regular
|
14 Participants
n=60 Participants
|
11 Participants
n=60 Participants
|
16 Participants
n=60 Participants
|
41 Participants
n=180 Participants
|
|
Statin use
No, never regularly
|
44 Participants
n=60 Participants
|
48 Participants
n=60 Participants
|
43 Participants
n=60 Participants
|
135 Participants
n=180 Participants
|
PRIMARY outcome
Timeframe: 8-12 weeksMeasured using liquid chromatography/mass spectrometry
Outcome measures
| Measure |
Placebo (For Aspirin)
n=58 Participants
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.
Placebo for Aspirin
|
Low Dose Aspirin
n=57 Participants
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.
Aspirin
|
Standard Dose Aspirin
n=54 Participants
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.
Aspirin
|
|---|---|---|---|
|
Change in Urinary Prostaglandin Metabolites (PGE-M)
Change in urinary PGE-M
|
0.8 ng/mg cr
Standard Deviation 11.8
|
-4.6 ng/mg cr
Standard Deviation 17.7
|
-4.9 ng/mg cr
Standard Deviation 11.2
|
|
Change in Urinary Prostaglandin Metabolites (PGE-M)
Baseline urinary PGE-M
|
15.5 ng/mg cr
Standard Deviation 12.6
|
17.7 ng/mg cr
Standard Deviation 17.1
|
14.3 ng/mg cr
Standard Deviation 13.7
|
|
Change in Urinary Prostaglandin Metabolites (PGE-M)
Post-intervention urinary PGE-M
|
16.4 ng/mg cr
Standard Deviation 15.8
|
13.1 ng/mg cr
Standard Deviation 13.4
|
9.4 ng/mg cr
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 8-12 weeksMeasured using an ELISA for MIC-1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8-12 weeksMeasured using ChIP-Seq of DNA extracted from colonic epithelium
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8-12 weeksMeasured using RNA-seq of colonic epithelium
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8-12 weeksMeasured using Partial Wave Spectroscopy on rectal cytology brushing samples
Outcome measures
Outcome data not reported
Adverse Events
Placebo (For Aspirin)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Low Dose Aspirin
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Standard Dose Aspirin
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (For Aspirin)
n=60 participants at risk
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.
Placebo for Aspirin
|
Low Dose Aspirin
n=60 participants at risk
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.
Aspirin
|
Standard Dose Aspirin
n=60 participants at risk
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.
Aspirin
|
|---|---|---|---|
|
General disorders
Fever
|
1.7%
1/60 • 3 months
|
0.00%
0/60 • 3 months
|
3.3%
2/60 • 3 months
|
|
Nervous system disorders
Headaches
|
0.00%
0/60 • 3 months
|
1.7%
1/60 • 3 months
|
0.00%
0/60 • 3 months
|
|
General disorders
Other, unrelated
|
3.3%
2/60 • 3 months
|
1.7%
1/60 • 3 months
|
1.7%
1/60 • 3 months
|
|
Gastrointestinal disorders
GI upset (i.e. heartburn/acid reflux/nausea/gas)
|
6.7%
4/60 • 3 months
|
10.0%
6/60 • 3 months
|
5.0%
3/60 • 3 months
|
|
General disorders
Unrelated infection/cold symptoms/sinus related
|
10.0%
6/60 • 3 months
|
8.3%
5/60 • 3 months
|
6.7%
4/60 • 3 months
|
|
Blood and lymphatic system disorders
Extended bleeding/bruising
|
0.00%
0/60 • 3 months
|
0.00%
0/60 • 3 months
|
3.3%
2/60 • 3 months
|
|
Gastrointestinal disorders
Bleeding hemorrhoids
|
0.00%
0/60 • 3 months
|
0.00%
0/60 • 3 months
|
1.7%
1/60 • 3 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/60 • 3 months
|
3.3%
2/60 • 3 months
|
1.7%
1/60 • 3 months
|
|
General disorders
Seasonal allergies
|
1.7%
1/60 • 3 months
|
3.3%
2/60 • 3 months
|
5.0%
3/60 • 3 months
|
Additional Information
Andrew T. Chan, MD, MPH
Massachusetts General Hospital
Phone: (617) 726-3212
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place