PRevention Using EPA Against coloREctal Cancer

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    80
  • sponsor
    Massachusetts General Hospital
Updated on 3 May 2021

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).

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.

Details
Condition Colorectal Cancer, Rectal disorder, Endoscopy, Eicosapentaenoic Acid, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Colorectal Adenomas, Colorectal Adenoma, Gastrointestinal Microbiome, colorectal neoplasm, eicosapentanoic acid, eicosapentaenoic acid (epa), colorectal cancers, endoscopic surgery, endoscopic procedures, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment AMR101, AMR101
Clinical Study IdentifierNCT04216251
SponsorMassachusetts General Hospital
Last Modified on3 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note