Boston, Massachusetts 02114


Purpose:

This is a prospective, double-blind, placebo-controlled, stratified, randomized clinical trial to assess the effects of daily 4-gram marine omega-3 polyunsaturated fatty acid (MO3PUFA), through treatment with AMR101 (VASCEPA, icosapent ethyl) on the tumor immune microenvironment and gut microbiome in patients who are diagnosed with colon cancer and will undergo surgical resection at the Massachusetts General Hospital (MGH). It uses the novel "window-of-opportunity" clinical trial design to take advantage of the window of time between cancer diagnosis and surgery to examine the effect of therapeutic agents on tumor pathologic and molecular features unperturbed by prior therapies.


Criteria:

Inclusion Criteria: - Participants must have histologically confirmed adenocarcinoma of the colon that is localized, with no evidence of distant metastasis (stage I, II, or III), and for which surgical resection of the primary tumor is being planned; OR Participants may have a colon biopsy that is suspicious for adenocarcinoma if clinical and/or endoscopic findings strongly support the presence of malignancy, and if surgical resection is being planned. NOTE: In the unlikely event that the final pathology of the surgical resection specimen is consistent with high-grade adenoma or dysplasia, the patient will not be considered ineligible and collected research samples will still be utilized. - Age >=18 years and <= 75 years. - ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) - Patients must be sufficiently healthy to undergo surgery - 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: - Prior systemic or radiotherapy treatment for colorectal cancer. - Participants who are receiving any other investigational agents. - Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol. - Inability or unwillingness to swallow pills. - History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease that could interfere with absorption of oral medications. - History of allergic reactions attributed to fish or compounds of similar chemical or biologic composition to MO3PUFA. - 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. - Known bleeding tendency/condition (e.g. von Willebrand disease) - Any 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, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results. - Pregnant or breastfeeding. - Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment. - Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.


NCT ID:

NCT03661047


Primary Contact:

Principal Investigator
Mingyang Song, MD, ScD
Massachusetts General Hospital

Mingyang Song, MD, ScD
Phone: 6176434464
Email: mis911@mail.harvard.edu


Backup Contact:

Email: dczerjav@mgh.harvard.edu
Dylan Zerjav
Phone: 2034500710


Location Contact:

Boston, Massachusetts 02114
United States

Mingyang Song, MD, ScD
Phone: 617-643-4464
Email: mis911@mail.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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