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



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:12/2/2018
Start Date:November 2018
End Date:September 2023
Contact:Mingyang Song, MD, ScD
Email:mis911@mail.harvard.edu
Phone:6176434464

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OMICC: OMega-3 Fatty Acid for the Immune Modulation of Colon Cancer

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.


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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-4464
?
mi
from
Boston, MA
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