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Trial record 13 of 1690 for:    colon cancer AND Intestinal Neoplasms

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661047
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Mingyang Song, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 31, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date November 19, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03661047 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • 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
  • Gene expression profile of tumor tissue [ Time Frame: An average of 2 years after study completion ]
    Gene expression profile of tumor tissue
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OMega-3 Fatty Acid for the Immune Modulation of Colon Cancer
Official Title  ICMJE OMICC: OMega-3 Fatty Acid for the Immune Modulation of Colon Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Colon Cancer
Intervention  ICMJE Drug: AMR101 (VASCEPA, icosapent ethyl)
Oral administration, 4 grams per day
Other Name: Omega-3 fatty acid
Study Arms  ICMJE
  • Active Comparator: Omega-3 treatment
    Daily 4-gram marine omega-3 polyunsaturated fatty acid (MO3PUFA), through treatment with AMR101 (VASCEPA, icosapent ethyl)
    Intervention: Drug: AMR101 (VASCEPA, icosapent ethyl)
  • Placebo Comparator: Placebo
    Identical placebo
    Intervention: Drug: AMR101 (VASCEPA, icosapent ethyl)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mingyang Song, MD, ScD 6176434464 mis911@mail.harvard.edu
Contact: Dylan Zerjav 2034500710 dczerjav@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03661047
Other Study ID Numbers  ICMJE 18-097
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mingyang Song, Massachusetts General Hospital
Study Sponsor  ICMJE Mingyang Song
Collaborators  ICMJE Harvard School of Public Health
Investigators  ICMJE
Principal Investigator: Mingyang Song, MD, ScD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP