Trial Outcomes & Findings for PRevention Using EPA Against coloREctal Cancer (NCT NCT04216251)
NCT ID: NCT04216251
Last Updated: 2024-05-03
Results Overview
Measured using the extraction of fatty acid with gas chromatography-mass spectrometry from the biopsy tissue.
COMPLETED
PHASE1/PHASE2
81 participants
8-12 weeks
2024-05-03
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 December 2020 and ended in September 2022.
Participant milestones
| Measure |
AMR101
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy. Participants will be expected to take 4 0.5 gram capsules orally, twice daily (daily dose of 4 grams) for a minimum of 8 weeks and maximum of 12 weeks
|
|---|---|
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Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PRevention Using EPA Against coloREctal Cancer
Baseline characteristics by cohort
| Measure |
AMR101
n=81 Participants
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy. Participants will be expected to take 4 0.5 gram capsules orally, twice daily (daily dose of 4 grams) for a minimum of 8 weeks and maximum of 12 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=93 Participants
|
|
Age, Continuous
|
61.95 years
STANDARD_DEVIATION 8.91 • n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 8-12 weeksMeasured using the extraction of fatty acid with gas chromatography-mass spectrometry from the biopsy tissue.
Outcome measures
| Measure |
Pre-treatment
n=59 Participants
This is the baseline (e.g., pre-treatment) measurement.
|
Post-treatment
n=59 Participants
This is the post-treatment measurement.
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|---|---|---|
|
Change in the Marine Omega-3 Polyunsaturated Fatty Acid (MO3PUFA) Composition in Colorectal Tissues as a Result of the AMR101 Treatment.
|
0.54 percentage of total fatty acids
Standard Deviation 0.33
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2.95 percentage of total fatty acids
Standard Deviation 1.65
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SECONDARY outcome
Timeframe: 8-12 weeks 8-12 weeks 8-12 weeks 8-12 weeksPopulation: This is after quality control filtering and excluding participants who had missing pre- or post-treatment samples.
Measured using shotgun metagenomic sequencing of microbial DNA on pre- and post-treatment stool samples. The reported results represent the Shannon Diversity Index, which is a quantitative measure that reflects how many different bacterial species there are in a sample. The index's values range from 0 to 5, but usually range from 1.5 to 3.5. The greater the index, the more diverse the gut microbiota. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity. We used the vegan R package to conduct the analysis.
Outcome measures
| Measure |
Pre-treatment
n=67 Participants
This is the baseline (e.g., pre-treatment) measurement.
|
Post-treatment
n=67 Participants
This is the post-treatment measurement.
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|---|---|---|
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Change in the Gut Microbiome Composition
|
3.082 Shannon diversity index
Interval 2.927 to 3.266
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3.133 Shannon diversity index
Interval 2.968 to 3.281
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SECONDARY outcome
Timeframe: 8-12 weeksPopulation: This is after quality control filtering and excluding participants who had missing pre- or post-treatment samples.
Butyrate is the metabolite of our most interest for the current study, based on the prior data suggesting that marine omega-3 fatty acid may increase the production of butyrate by bacterial fermentation of dietary fiber. The metabolites were measured by the non-targeted global metabolomic panel. The measurement represents the abundance (assessed as weight percentage of density) of a metabolite after total-signal normalization to account for varying water weight across stool samples.
Outcome measures
| Measure |
Pre-treatment
n=64 Participants
This is the baseline (e.g., pre-treatment) measurement.
|
Post-treatment
n=64 Participants
This is the post-treatment measurement.
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|---|---|---|
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Change in Fecal Metabolite Levels (Butyrate)
|
0.64 Weight percentage of butyrate density
Interval 0.42 to 0.81
|
0.63 Weight percentage of butyrate density
Interval 0.39 to 0.76
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Adverse Events
AMR101
Serious adverse events
| Measure |
AMR101
n=81 participants at risk
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy. Participants will be expected to take 4 0.5 gram capsules orally, twice daily (daily dose of 4 grams) for a minimum of 8 weeks and maximum of 12 weeks
|
|---|---|
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Vascular disorders
Ischemic right foot with thrombosis of right external iliac artery stent and common femoral artery
|
1.2%
1/81 • 3 months
|
Other adverse events
| Measure |
AMR101
n=81 participants at risk
The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy. Participants will be expected to take 4 0.5 gram capsules orally, twice daily (daily dose of 4 grams) for a minimum of 8 weeks and maximum of 12 weeks
|
|---|---|
|
Gastrointestinal disorders
GI Upset (i.e. nausea/gas/diarrhea/constipation/stomach ache/loss of appetite)
|
14.8%
12/81 • 3 months
|
|
Infections and infestations
COVID and Flu-like symptoms (congestion, chills, fever, body ache, headache)
|
4.9%
4/81 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
2.5%
2/81 • 3 months
|
|
Skin and subcutaneous tissue disorders
Skin issues (acne, hyperpigmentation)
|
2.5%
2/81 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain (joint pain, muscle aches)
|
3.7%
3/81 • 3 months
|
|
Gastrointestinal disorders
Esophagitis
|
1.2%
1/81 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place