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Omega-3 Fatty Acid

AMR101 for Colorectal Cancer (PREPARE Trial)

Phase 1 & 2
Waitlist Available
Led By Mingyang Song, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after study completion
Awards & highlights

PREPARE Trial Summary

This trial is being conducted to study the effects of AMR101 as a potential chemopreventive agent to reduce the risk of colorectal cancer in patients with a history of colorectal adenoma.

Eligible Conditions
  • Colorectal Adenomas
  • Colorectal Cancer
  • Endoscopy
  • Eicosapentaenoic Acid
  • Gastrointestinal Microbiome

PREPARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Marine Omega-3 Polyunsaturated Fatty Acid (MO3PUFA) Composition in Colorectal Tissues as a Result of the AMR101 Treatment.
Secondary outcome measures
Change in Stool Metabolite Profile
Change in the Gut Microbiome Composition
Other outcome measures
The change in gene expression profile of colorectal tissue between pre- and post- AMR101 treatment period.
The change in stool metabolomics between pre- and post- AMR101 treatment period.

Side effects data

From 2018 Phase 3 trial • 8179 Patients • NCT01492361
9%
Diarrhoea
8%
Hypertension
8%
Nasopharyngitis
8%
Upper respiratory tract infection
8%
Back pain
8%
Arthralgia
7%
Bronchitis
6%
Cataract
6%
Influenza
6%
Cough
6%
Dizziness
6%
Dyspnoea
6%
Fatigue
6%
Urinary tract infection
6%
Oedema peripheral
6%
Chest pain
6%
Pain in extremity
5%
Constipation
4%
Anaemia
3%
Pneumonia
2%
Osteoarthritis
1%
Syncope
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Non-cardiac chest pain
1%
Cellulitis
1%
Prostate cancer
1%
Angina pectoris
1%
Angina unstable
1%
Chronic obstructive pulmonary disease
1%
Sepsis
1%
Acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
AMR101
Placebo

PREPARE Trial Design

1Treatment groups
Experimental Treatment
Group I: AMR101Experimental Treatment1 Intervention
Study procedures include screening for eligibility and study treatment including ARM101 Lifestyle questionnaire, Nutritional survey. Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample),blood, evaluations, and follow up visits. - AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Icosapent ethyl
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,364 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,238 Total Patients Enrolled
Mingyang Song, MD1.01 ReviewsPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
1 Previous Clinical Trials
80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PRevention Using EPA Against coloREctal Cancer
Mingyang Song 2020. "PRevention Using EPA Against coloREctal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04216251.
~19 spots leftby Apr 2025
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