OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer

Status Withdrawn

Clinical Trial Summary

This is a prospective, double-blind, placebo-controlled, 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 colorectal cancer or with a colorectal mass or polyp suspected to be a cancer or advanced adenoma and will undergo surgical resection or interventional endoscopy 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/mass/polyp diagnosis and surgery to examine the effect of therapeutic agents on tumor pathologic and molecular features unperturbed by prior therapies.

Clinical Trial Description

This research study is evaluating the effect of AMR101, as a chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal cancer, colorectal mass or polyp(s). 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 during which participants will complete a lifestyle questionnaire and a nutritional survey. A drug diary will be provided to be completed. Measurements will be taken, and blood and stool specimens will be collected. Tumor, colorectal mass, or polyp tissue will be collected for research purposes at the time of surgery or interventional endoscopy. AMR101 administered daily, orally for up to 30 days and it is expected that 36 participants will take part in this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03661047
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Withdrawn
Phase	Phase 2
Start date	November 30, 2019
Completion date	November 30, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer — OMICC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms