Colorectal AdenomaPhase 1/2PREPARENCT04216251
PRevention Using EPA Against coloREctal Cancer
A Phase 1/2 study testing AMR101 in people with Colorectal Adenoma and Colorectal Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma. The name of the study drug involved in this study is: -- AMR101 (VASCEPA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Adenoma, Colorectal Cancer, Endoscopic Surgery
- What is being tested?
- AMR101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 30 Sep 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Underwent screening or surveillance colonoscopy with removal of at least one adenoma;
- Age 18-80 years.
- This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults. Patients over age 80 will not be enrolled since the benefits and risks of AMR101 over the age of 80 have not yet been well-characterized.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- The effects of AMR101 on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
- Subjects must be able and willing to follow study procedures and instructions.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study
- Currently using or have used any fish oil supplement at any dose more than once per week within the last month
- Regularly consuming more than three servings of fish per week.
- History of allergic reactions attributed to fish or compounds of similar chemical or biologic composition to omega-3 fatty acid.
- Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis
- Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of nonmelanoma skin) in which there has been any active treatment within the last three years.
Show all 16Show fewer
- Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).
- Any adenoma that was not completely removed during previous colonoscopy.
- Known bleeding tendency/condition (e.g. von Willebrand disease) or history of peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy.
- Current use of anticoagulant therapies, including Heparin, Warfarin, Dalteparin sodium,Bivalirudin, Argatroban, Lepirudin, Heparin Sodium, Heparin/Dextrose, and an unwillingness or inability to discontinue anticoagulants.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Inability or unwillingness to abstain from non-protocol use of fish oil supplements or to provide blood or stool samples or colon biopsies during the study.
- Participants who are receiving any other investigational agents.
- Inability or unwillingness to swallow pills.
- Pregnant or breastfeeding. The effects of AMR101 on the developing human fetus are unknown. For this reason,women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Similarly, lactating women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with AMR101. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.
- Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection. Participants with these infections are ineligible because they are at increased risk of significant complications in the perioperative period, and because fresh tissue from patients with these infections cannot be harvested for research purposes, per institutional policy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: PREPARE: PRevention Using EPA Against coloREctal Cancer
This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.
- The name of the study drug involved in this study is:
-- AMR101 (VASCEPA).
Read the detailed description
This prospective, single-arm, research study evaluating the effect of AMR101, as a chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.
- AMR101 is made of marine omega-3 fatty acid, which is a family of natural substances found in the oil of certain fish, such as salmon and mackerel. Marine omega-3 fatty acid cannot be produced in sufficient amount by the human body and has to be obtained through diet or supplemented to maintain normal function in the body.
- The U.S. Food and Drug Administration (FDA) has not approved AMR101 as a treatment for any disease.
- AMR101 is commercially available in the US as VASCEPA (icosapent ethyl)
- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, including:
- Lifestyle questionnaire,
- Nutritional survey
- Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample)
- Blood samples,
- AMR101 administered daily, orally for 8-12 weeks and it is expected 80 participants will take part.
- Conditions
- Colorectal Adenoma, Colorectal Cancer, Endoscopic Surgery, Eicosapentaenoic Acid, Gastrointestinal Microbiome
- Being tested
- AMR101
- Keywords
- Colorectal Adenoma, Colorectal Cancer, colonoscopic Surgery, Endoscopic Surgery, Eicosapentaenoic acid, Gastrointestinal Microbiome, Mucosal Tissue
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMR101Drug
Also called VASCEPA
AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| AMR101 | Experimental | Study procedures include screening for eligibility and study treatment including ARM101 Lifestyle questionnaire, Nutritional survey. Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample),blood, evaluations, and follow up visits.
- AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks Receives: Drug: AMR101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Marine Omega-3 Polyunsaturated Fatty Acid (MO3PUFA) Composition in Colorectal Tissues as a Result of the AMR101 Treatment.
Measured using the extraction of fatty acid with gas chromatography-mass spectrometry from the biopsy tissue.
Measured: 8-12 weeks
Secondary outcomes (2)
Change in the Gut Microbiome Composition
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.
Measured: 8-12 weeks 8-12 weeks 8-12 weeks 8-12 weeks
Change in Fecal Metabolite Levels (Butyrate)
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.
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start9 Dec 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Mingyang Song, Massachusetts General Hospital
- Investigators
- Mingyang Song, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216251
- Sponsor's protocol ID
- 19-402
- Acronym
- PREPARE
- Status last verified
- Apr 2024
- First submitted
- 19 Dec 2019
- Last updated
- 3 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Chen Y, Bae S, Wang K, Du M, Lu Y, Sun Q, Labelle PA, Caraballo A, Lachut K, Husain A, Hote L, Koehn M, Prezioso E, Reinicke T, Schuck M, Sethurathnam J, Solowey J, Woo J, Carolan PJ, Chung DC, Colizzo FP 3rd, Gala M, Khalili H, Nishioka NS, Richter JM, Staller K, Yarze JC, Ma W, Pratt D, Singh A, Nguyen LH, Jacobson BC, Luther J, Kuo B, Dougan M, Rosner B, Magicheva-Gupta M, Drew DA, Chan AT, Song M. Effect of icosapent ethyl treatment on colorectal tissue marine omega-3 polyunsaturated fatty acid levels among patients with a history of adenoma: a prospective, single-arm clinical trial. Am J Clin Nutr. 2026 Jun 25;124(3):101419. doi: 10.1016/j.ajcnut.2026.101419. Online ahead of print.
PubMed 42349681
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE: PRevention Using EPA Against coloREctal Cancer
- ClinicalTrials.gov ID
- NCT04216251
- Acronym / sponsor ID
- PREPARE / 19-402
- Conditions
- Colorectal Adenoma, Colorectal Cancer, Endoscopic Surgery, Eicosapentaenoic Acid, Gastrointestinal Microbiome
- Keywords
- Colorectal Adenoma, Colorectal Cancer, colonoscopic Surgery, Endoscopic Surgery, Eicosapentaenoic acid, Gastrointestinal Microbiome, Mucosal Tissue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.
- The name of the study drug involved in this study is:
-- AMR101 (VASCEPA).
Detailed description
This prospective, single-arm, research study evaluating the effect of AMR101, as a chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.
- AMR101 is made of marine omega-3 fatty acid, which is a family of natural substances found in the oil of certain fish, such as salmon and mackerel. Marine omega-3 fatty acid cannot be produced in sufficient amount by the human body and has to be obtained through diet or supplemented to maintain normal function in the body.
- The U.S. Food and Drug Administration (FDA) has not approved AMR101 as a treatment for any disease.
- AMR101 is commercially available in the US as VASCEPA (icosapent ethyl)
- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, including:
- Lifestyle questionnaire,
- Nutritional survey
- Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample)
- Blood samples,
- AMR101 administered daily, orally for 8-12 weeks and it is expected 80 participants will take part.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMR101 | Experimental | Drug: AMR101Study procedures include screening for eligibility and study treatment including ARM101 Lifestyle questionnaire, Nutritional survey. Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample),blood, evaluations, and follow up visits. - AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Underwent screening or surveillance colonoscopy with removal of at least one adenoma;
- Age 18-80 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- The effects of AMR101 on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (16 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study
- Currently using or have used any fish oil supplement at any dose more than once per week within the last month
- Regularly consuming more than three servings of fish per week.
- History of allergic reactions attributed to fish or compounds of similar chemical or biologic composition to omega-3 fatty acid.
- Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMR101Also: VASCEPAAMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks | Drug | AMR101 |
Primary outcome
Change in the Marine Omega-3 Polyunsaturated Fatty Acid (MO3PUFA) Composition in Colorectal Tissues as a Result of the AMR101 Treatment.
Time frame: 8-12 weeks
Measured using the extraction of fatty acid with gas chromatography-mass spectrometry from the biopsy tissue.
2 secondary outcomes
Change in the Gut Microbiome Composition
Time frame: 8-12 weeks 8-12 weeks 8-12 weeks 8-12 weeks
Change in Fecal Metabolite Levels (Butyrate)
Time frame: 8-12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42349681Chen Y, Bae S, Wang K, Du M, Lu Y, Sun Q, Labelle PA, Caraballo A, Lachut K, Husain A, Hote L, Koehn M, Prezioso E, Reinicke T, Schuck M, Sethurathnam J, Solowey J, Woo J, Carolan PJ, Chung DC, Colizzo FP 3rd, Gala M, Khalili H, Nishioka NS, Richter JM, Staller K, Yarze JC, Ma W, Pratt D, Singh A, Nguyen LH, Jacobson BC, Luther J, Kuo B, Dougan M, Rosner B, Magicheva-Gupta M, Drew DA, Chan AT, Song M. Effect of icosapent ethyl treatment on colorectal tissue marine omega-3 polyunsaturated fatty acid levels among patients with a history of adenoma: a prospective, single-arm clinical trial. Am J Clin Nutr. 2026 Jun 25;124(3):101419. doi: 10.1016/j.ajcnut.2026.101419. Online ahead of print.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingyang Song, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AMR101 in people with Colorectal Adenoma and Colorectal Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Marine Omega-3 Polyunsaturated Fatty Acid (MO3PUFA) Composition in Colorectal Tissues as a Result of the AMR101 Treatment. (time frame: 8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.