Trial Outcomes & Findings for Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA (NCT NCT00510692)
NCT ID: NCT00510692
Last Updated: 2014-08-22
Results Overview
Absolute change in the number of polyps measured in a defined focal area of the rectum.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
58 participants
Primary outcome timeframe
6 months compared to baseline.
Results posted on
2014-08-22
Participant Flow
Single centre study (Polyposis Registry).
Participant milestones
| Measure |
2g/Day Eicosapentaenoic Acid (EPA)
Eicosapentaenoic Acid (EPA) 2g per day for six months
|
Placebo
Medium chain triglycerides 2 g per day for six months.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
2g/Day Eicosapentaenoic Acid (EPA)
Eicosapentaenoic Acid (EPA) 2g per day for six months
|
Placebo
Medium chain triglycerides 2 g per day for six months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA
Baseline characteristics by cohort
| Measure |
2g/Day EPA
n=28 Participants
Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).
|
Placebo
n=27 Participants
Medium chain triglycerides 2 capsules twice daily for six months.
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 11.4 • n=113 Participants
|
42.5 years
STANDARD_DEVIATION 13.8 • n=163 Participants
|
40.1 years
STANDARD_DEVIATION 12.6 • n=160 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=113 Participants
|
26 Participants
n=163 Participants
|
54 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=113 Participants
|
12 Participants
n=163 Participants
|
27 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=113 Participants
|
15 Participants
n=163 Participants
|
28 Participants
n=160 Participants
|
|
Region of Enrollment
United Kingdom
|
28 participants
n=113 Participants
|
27 participants
n=163 Participants
|
55 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 6 months compared to baseline.Population: 13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.
Absolute change in the number of polyps measured in a defined focal area of the rectum.
Outcome measures
| Measure |
2g/Day Eicosapentaenoic Acid (EPA)
n=23 Participants
Eicosapentaenoic Acid (EPA) 2g per day for six months
|
Placebo
n=22 Participants
Medium chain triglycerides 2g per day for six months
|
|---|---|---|
|
Absolute Change in the Number of Polyps Measured in a Focal Area of the Rectum.
|
-0.5 Change from baseline number of polyps.
Standard Deviation 0.9
|
0.5 Change from baseline number of polyps.
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 6 months compared to baseline.Population: 13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.
Percentage change in the number of polyps measured in the defined focal area of the rectum in subjects treated with EPA compared to subjects receiving placebo.
Outcome measures
| Measure |
2g/Day Eicosapentaenoic Acid (EPA)
n=23 Participants
Eicosapentaenoic Acid (EPA) 2g per day for six months
|
Placebo
n=22 Participants
Medium chain triglycerides 2g per day for six months
|
|---|---|---|
|
Percentage Change in the Number of Polyps Measured in the Defined Focal Area of the Rectum.
|
-12.6 percentage of change in total polyps
Interval -24.7 to -0.6
|
9.7 percentage of change in total polyps
Interval -2.6 to 22.0
|
SECONDARY outcome
Timeframe: 6 months compared to baseline.Population: 5 subjects in the full analysis set lacked the video required for determining global rectal polyp burden due to failure of equipment.
Change in global rectal polyp burden in subjects treated with Eicosapentanoic Acid (EPA) compared to subjects receiving placebo. Each reviewer in the Polyp Video Scoring Committee assessed global colorectal polyp burden change as "better", "same as" or "worse". The qualitative assessment was assigned a score of +1 for "better", 0 for "same as" and -1 for "worse". Thereafter a mean overall reviewers score was calculated.
Outcome measures
| Measure |
2g/Day Eicosapentaenoic Acid (EPA)
n=25 Participants
Eicosapentaenoic Acid (EPA) 2g per day for six months
|
Placebo
n=25 Participants
Medium chain triglycerides 2g per day for six months
|
|---|---|---|
|
Change in Global Rectal Polyp Burden.
|
0.09 units on a scale
Interval -0.14 to 0.32
|
-0.34 units on a scale
Interval -0.56 to -0.11
|
SECONDARY outcome
Timeframe: 6 months compared to baseline.Population: 3 subjects in the full analysis set had no samples for analysis.
Relative EPA concentration of total free fatty acids in the rectal mucosa of subjects with FAP.
Outcome measures
| Measure |
2g/Day Eicosapentaenoic Acid (EPA)
n=26 Participants
Eicosapentaenoic Acid (EPA) 2g per day for six months
|
Placebo
n=26 Participants
Medium chain triglycerides 2g per day for six months
|
|---|---|---|
|
Relative EPA Concentration of Total Free Fatty Acids in the Rectal Mucosa.
|
1.56 percentage of total fatty acid content
Interval 0.97 to 2.15
|
0.54 percentage of total fatty acid content
Interval -0.06 to 1.13
|
SECONDARY outcome
Timeframe: 6 months compared to baselineIncidence of adverse events in each treatment group.
Outcome measures
| Measure |
2g/Day Eicosapentaenoic Acid (EPA)
n=29 Participants
Eicosapentaenoic Acid (EPA) 2g per day for six months
|
Placebo
n=29 Participants
Medium chain triglycerides 2g per day for six months
|
|---|---|---|
|
Number of Subjects With Adverse Events.
|
25 participants
|
25 participants
|
Adverse Events
2g/Day Eicosapentanoic Acid (EPA)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2g/Day Eicosapentanoic Acid (EPA)
n=29 participants at risk
Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).
|
Placebo
n=29 participants at risk
Medium chain triglycerides 2 capsules twice daily for six months.
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).
|
|---|---|---|
|
Gastrointestinal disorders
Small bowel obstruction
|
6.9%
2/29 • Number of events 2 • 6 months
|
0.00%
0/29 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
3.4%
1/29 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
Other adverse events
| Measure |
2g/Day Eicosapentanoic Acid (EPA)
n=29 participants at risk
Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).
|
Placebo
n=29 participants at risk
Medium chain triglycerides 2 capsules twice daily for six months.
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).
|
|---|---|---|
|
Eye disorders
Eye disorders
|
0.00%
0/29 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Endocrine disorders
Endocrine disorders
|
3.4%
1/29 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal
|
79.3%
23/29 • Number of events 68 • 6 months
|
75.9%
22/29 • Number of events 61 • 6 months
|
|
General disorders
General disorders
|
24.1%
7/29 • Number of events 8 • 6 months
|
31.0%
9/29 • Number of events 11 • 6 months
|
|
Immune system disorders
Immune system disorders
|
3.4%
1/29 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Infections and infestations
Infections and infestations
|
27.6%
8/29 • Number of events 11 • 6 months
|
24.1%
7/29 • Number of events 7 • 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
13.8%
4/29 • Number of events 4 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Investigations
Investigations
|
3.4%
1/29 • Number of events 1 • 6 months
|
17.2%
5/29 • Number of events 5 • 6 months
|
|
Metabolism and nutrition disorders
metabolism and nutritional disorders
|
3.4%
1/29 • Number of events 1 • 6 months
|
6.9%
2/29 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
24.1%
7/29 • Number of events 10 • 6 months
|
27.6%
8/29 • Number of events 9 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
6.9%
2/29 • Number of events 2 • 6 months
|
0.00%
0/29 • 6 months
|
|
Nervous system disorders
Nervous system disorders
|
37.9%
11/29 • Number of events 19 • 6 months
|
20.7%
6/29 • Number of events 6 • 6 months
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/29 • 6 months
|
6.9%
2/29 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders
|
3.4%
1/29 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.00%
0/29 • 6 months
|
10.3%
3/29 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
17.2%
5/29 • Number of events 5 • 6 months
|
13.8%
4/29 • Number of events 4 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
3.4%
1/29 • Number of events 1 • 6 months
|
10.3%
3/29 • Number of events 3 • 6 months
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/29 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60