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

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ClinicalTrials.gov Identifier: NCT03661047
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Mingyang Song, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: AMR101 (VASCEPA, icosapent ethyl) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled, stratified, randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: OMICC: OMega-3 Fatty Acid for the Immune Modulation of Colon Cancer
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Omega-3 treatment
Daily 4-gram marine omega-3 polyunsaturated fatty acid (MO3PUFA), through treatment with AMR101 (VASCEPA, icosapent ethyl)
Drug: AMR101 (VASCEPA, icosapent ethyl)
Oral administration, 4 grams per day
Other Name: Omega-3 fatty acid

Placebo Comparator: Placebo
Identical placebo
Drug: AMR101 (VASCEPA, icosapent ethyl)
Oral administration, 4 grams per day
Other Name: Omega-3 fatty acid




Primary Outcome Measures :
  1. Marine omega-3 polyunsaturated fatty acid (MO3PUFA) composition [ Time Frame: An average of 2 years after study completion ]
    To measure the effect of daily 4-gram AMR101 treatment on MO3PUFA composition in both the tumor and adjacent normal tissue


Secondary Outcome Measures :
  1. Tumor CD8+ T cell: regulatory T (Treg) cell ratios [ Time Frame: An average of 2 years after study completion ]
    Tumor CD8+ T cell: regulatory T (Treg) cell ratios

  2. Gene expression profile of tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Gene expression profile of tumor tissue

  3. Protein levels of FOXP3 in the tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Protein levels of FOXP3 in the tumor tissue

  4. Protein levels of IL10 in the tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Protein levels of IL10 in the tumor tissue

  5. Protein levels of LAG-3 in the tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Protein levels of LAG-3 in the tumor tissue

  6. Protein levels of CD49b in the tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Protein levels of CD49b in the tumor tissue

  7. Protein levels of CTLA-4 in the tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Protein levels of CTLA-4 in the tumor tissue

  8. Protein levels of TIGIT in the tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Protein levels of TIGIT in the tumor tissue

  9. Protein levels of TIM-3 in the tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Protein levels of TIM-3 in the tumor tissue

  10. Protein levels of PD-1 in the tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Protein levels of PD-1 in the tumor tissue

  11. Protein levels of PD-L1 in the tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Protein levels of PD-L1 in the tumor tissue

  12. Gut microbiome [ Time Frame: An average of 2 years after study completion ]
    Metagenomic and metatranscriptomic sequencing of microbial DNA and RNA on pre- and post-treatment stool samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661047


Contacts
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Contact: Mingyang Song, MD, ScD 6176434464 mis911@mail.harvard.edu
Contact: Dylan Zerjav 2034500710 dczerjav@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mingyang Song, MD, ScD    617-643-4464    mis911@mail.harvard.edu   
Sponsors and Collaborators
Mingyang Song
Harvard School of Public Health
Investigators
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Principal Investigator: Mingyang Song, MD, ScD Massachusetts General Hospital

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Responsible Party: Mingyang Song, Prinicipal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03661047     History of Changes
Other Study ID Numbers: 18-097
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mingyang Song, Massachusetts General Hospital:
Nutrition
Omega-3 fatty acid
Fish oil
Tumor microenvironment
Immune response
Gut microbiota

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors