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ASPirin Intervention for the REDuction of Colorectal Cancer Risk (ASPIRED)

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: NCT02394769
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Results First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrew T. Chan, MD, MPH, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Colorectal Cancer
Interventions Drug: Aspirin
Drug: Placebo for Aspirin
Enrollment 180
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Placebo (For Aspirin) Low Dose Aspirin Standard Dose Aspirin
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 60 60 60
Completed 58 57 54
Not Completed 2 3 6
Arm/Group Title Placebo (For Aspirin) Low Dose Aspirin Standard Dose Aspirin Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 60 60 60 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 60 participants 180 participants
57.1  (9.2) 56.1  (8.7) 57.5  (8.3) 56.9  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Female
28
  46.7%
29
  48.3%
28
  46.7%
85
  47.2%
Male
32
  53.3%
31
  51.7%
32
  53.3%
95
  52.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Hispanic or Latino
2
   3.3%
2
   3.3%
1
   1.7%
5
   2.8%
Not Hispanic or Latino
58
  96.7%
58
  96.7%
59
  98.3%
175
  97.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.7%
0
   0.0%
2
   3.3%
3
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   5.0%
4
   6.7%
3
   5.0%
10
   5.6%
White
55
  91.7%
52
  86.7%
53
  88.3%
160
  88.9%
More than one race
0
   0.0%
4
   6.7%
2
   3.3%
6
   3.3%
Unknown or Not Reported
1
   1.7%
0
   0.0%
0
   0.0%
1
   0.6%
Marital status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Married
40
  66.7%
39
  65.0%
37
  61.7%
116
  64.4%
Never married
6
  10.0%
12
  20.0%
11
  18.3%
29
  16.1%
Separated
2
   3.3%
0
   0.0%
1
   1.7%
3
   1.7%
Divorced
8
  13.3%
7
  11.7%
7
  11.7%
22
  12.2%
Widowed
4
   6.7%
2
   3.3%
4
   6.7%
10
   5.6%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 60 participants 60 participants 60 participants 180 participants
26.8  (5.0) 28.4  (4.9) 27.5  (5.7) 27.6  (5.2)
Body Mass Index, categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Normal, <18.5-24.9
21
  35.0%
16
  26.7%
21
  35.0%
58
  32.2%
Overweight, 25.0-29.9
26
  43.3%
26
  43.3%
23
  38.3%
75
  41.7%
Obese ≥30.0
13
  21.7%
18
  30.0%
16
  26.7%
47
  26.1%
Smoking status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Never
38
  63.3%
36
  60.0%
32
  53.3%
106
  58.9%
Former
18
  30.0%
20
  33.3%
19
  31.7%
57
  31.7%
Current
4
   6.7%
3
   5.0%
8
  13.3%
15
   8.3%
Missing
0
   0.0%
1
   1.7%
1
   1.7%
2
   1.1%
Alcohol consumption  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Never
7
  11.7%
11
  18.3%
11
  18.3%
29
  16.1%
Rarely
14
  23.3%
16
  26.7%
18
  30.0%
48
  26.7%
1-5 times/week
29
  48.3%
24
  40.0%
23
  38.3%
76
  42.2%
Daily
10
  16.7%
8
  13.3%
6
  10.0%
24
  13.3%
More than daily
0
   0.0%
1
   1.7%
2
   3.3%
3
   1.7%
Personal cancer history, yes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
10
  16.7%
6
  10.0%
4
   6.7%
20
  11.1%
Family history of colorectal cancer, yes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
13
  21.7%
10
  16.7%
12
  20.0%
35
  19.4%
Type II diabetes, yes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
2
   3.3%
3
   5.0%
2
   3.3%
7
   3.9%
Menopause status   [1] 
Measure Type: Number
Unit of measure:  Participants
Premenopausal Number Analyzed 28 participants 29 participants 28 participants 85 participants
3 9 5 17
Perimenopausal Number Analyzed 28 participants 29 participants 28 participants 85 participants
4 1 2 7
Postmenopausal Number Analyzed 28 participants 29 participants 28 participants 85 participants
20 17 18 55
Missing Number Analyzed 28 participants 29 participants 28 participants 85 participants
1 2 3 6
[1]
Measure Analysis Population Description: Menopausal status of female participants, only
History of 81 mg aspirin use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Never
55
  91.7%
50
  83.3%
53
  88.3%
158
  87.8%
Intermittently (<2x/week)
2
   3.3%
5
   8.3%
5
   8.3%
12
   6.7%
Regularly (>2x/week)
2
   3.3%
2
   3.3%
2
   3.3%
6
   3.3%
Missing
1
   1.7%
3
   5.0%
0
   0.0%
4
   2.2%
History of 325 mg aspirin use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Never
40
  66.7%
42
  70.0%
42
  70.0%
124
  68.9%
Intermittently (<2x/week)
17
  28.3%
15
  25.0%
17
  28.3%
49
  27.2%
Regularly (>2x/week)
1
   1.7%
1
   1.7%
1
   1.7%
3
   1.7%
Missing
2
   3.3%
2
   3.3%
0
   0.0%
4
   2.2%
History of non-steroidal anti-inflammatory drug use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Never
18
  30.0%
13
  21.7%
19
  31.7%
50
  27.8%
Intermittently (<2x/week)
31
  51.7%
36
  60.0%
32
  53.3%
99
  55.0%
Regularly (>2x/week)
10
  16.7%
9
  15.0%
8
  13.3%
27
  15.0%
Missing
1
   1.7%
2
   3.3%
1
   1.7%
4
   2.2%
Proton pump inhibitor use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Current and regular
5
   8.3%
6
  10.0%
8
  13.3%
19
  10.6%
No, never regularly
48
  80.0%
49
  81.7%
48
  80.0%
145
  80.6%
Missing
7
  11.7%
5
   8.3%
4
   6.7%
16
   8.9%
H2-blocker use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Current and regular
2
   3.3%
5
   8.3%
2
   3.3%
9
   5.0%
No, never regularly
56
  93.3%
54
  90.0%
57
  95.0%
167
  92.8%
Missing
2
   3.3%
1
   1.7%
1
   1.7%
4
   2.2%
Antacid use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Current and regular
5
   8.3%
3
   5.0%
3
   5.0%
11
   6.1%
No, never regularly
54
  90.0%
57
  95.0%
57
  95.0%
168
  93.3%
Missing
1
   1.7%
0
   0.0%
0
   0.0%
1
   0.6%
Statin use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Current and regular
14
  23.3%
11
  18.3%
16
  26.7%
41
  22.8%
No, never regularly
44
  73.3%
48
  80.0%
43
  71.7%
135
  75.0%
Missing
2
   3.3%
1
   1.7%
1
   1.7%
4
   2.2%
1.Primary Outcome
Title Change in Urinary Prostaglandin Metabolites (PGE-M)
Hide Description Measured using liquid chromatography/mass spectrometry
Time Frame 8-12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (For Aspirin) Low Dose Aspirin Standard Dose Aspirin
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 58 57 54
Mean (Standard Deviation)
Unit of Measure: ng/mg cr
Baseline urinary PGE-M 15.5  (12.6) 17.7  (17.1) 14.3  (13.7)
Post-intervention urinary PGE-M 16.4  (15.8) 13.1  (13.4) 9.4  (7.9)
Change in urinary PGE-M 0.8  (11.8) -4.6  (17.7) -4.9  (11.2)
2.Secondary Outcome
Title Plasma Macrophage Inhibitory Cytokine-1 (MIC-1), an Inflammatory Biomarker
Hide Description Measured using an ELISA for MIC-1
Time Frame 8-12 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Chromatin Binding
Hide Description Measured using ChIP-Seq of DNA extracted from colonic epithelium
Time Frame 8-12 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Expression of Wnt-associated Signaling Genes (CTNNB1, AXIN2 and MYC)
Hide Description Measured using RNA-seq of colonic epithelium
Time Frame 8-12 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Spectral Biomarkers of Colorectal Cancer
Hide Description Measured using Partial Wave Spectroscopy on rectal cytology brushing samples
Time Frame 8-12 weeks
Outcome Measure Data Not Reported
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (For Aspirin) Low Dose Aspirin Standard Dose Aspirin
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Placebo (For Aspirin) Low Dose Aspirin Standard Dose Aspirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%)   0/60 (0.00%) 
Hide Serious Adverse Events
Placebo (For Aspirin) Low Dose Aspirin Standard Dose Aspirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo (For Aspirin) Low Dose Aspirin Standard Dose Aspirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/60 (23.33%)   17/60 (28.33%)   17/60 (28.33%) 
Blood and lymphatic system disorders       
Extended bleeding/bruising  1  0/60 (0.00%)  0/60 (0.00%)  2/60 (3.33%) 
Gastrointestinal disorders       
GI upset (i.e. heartburn/acid reflux/nausea/gas)  1  4/60 (6.67%)  6/60 (10.00%)  3/60 (5.00%) 
Bleeding hemorrhoids  1  0/60 (0.00%)  0/60 (0.00%)  1/60 (1.67%) 
Constipation  1  0/60 (0.00%)  2/60 (3.33%)  1/60 (1.67%) 
General disorders       
Unrelated infection/cold symptoms/sinus related  1  6/60 (10.00%)  5/60 (8.33%)  4/60 (6.67%) 
Seasonal allergies  1  1/60 (1.67%)  2/60 (3.33%)  3/60 (5.00%) 
Fever  1  1/60 (1.67%)  0/60 (0.00%)  2/60 (3.33%) 
Other, unrelated  1  2/60 (3.33%)  1/60 (1.67%)  1/60 (1.67%) 
Nervous system disorders       
Headaches  1  0/60 (0.00%)  1/60 (1.67%)  0/60 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew T. Chan, MD, MPH
Organization: Massachusetts General Hospital
Phone: (617) 726-3212
EMail: achan@partners.org
Layout table for additonal information
Responsible Party: Andrew T. Chan, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02394769    
Other Study ID Numbers: 14-496
R01CA137178 ( U.S. NIH Grant/Contract )
First Submitted: March 16, 2015
First Posted: March 20, 2015
Results First Submitted: January 29, 2021
Results First Posted: March 23, 2021
Last Update Posted: March 23, 2021