Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA

NCT00510692 | Completed Phase 2 Results

• 1 other identifier: EPA/POL/03
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of this study is to investigate whether the number and size of rectal polyps can be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified form of a naturally occurring substance, the omega-3 fatty acid, eicosapentaenoic acid (EPA).

Conditions

Familial Adenomatous Polyposis Coli; FAP

Keywords

Eicosapentaenoic Acid; EPA; EPA 99%; Fatty acid; omega-3; apoptosis; cell proliferation; colonic mucosa; polyp; Familial Adenomatous Polyposis Coli; FAP; resolvin; Ileo-rectal anastomosis; IRA; PUFA; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Absolute Change in the Number of Polyps Measured in a Focal Area of the Rectum.

  Absolute change in the number of polyps measured in a defined focal area of the rectum.

  6 months compared to baseline.

Secondary Outcomes (4)

• Percentage Change in the Number of Polyps Measured in the Defined Focal Area of the Rectum.

  6 months compared to baseline.

• Change in Global Rectal Polyp Burden.

  6 months compared to baseline.

• Relative EPA Concentration of Total Free Fatty Acids in the Rectal Mucosa.

  6 months compared to baseline.

• Number of Subjects With Adverse Events.

  6 months compared to baseline

Study Arms (2)

2g/day Eicosapentanoic Acid (EPA)

EXPERIMENTAL

Eicosapentanenoic Acid (EPA) as the free fatty acid 2 capsules twice daily for 6 months. Endoscopy and biopsies taken as described under intervention.

Drug: Eicosapentanoic Acid (EPA); Procedure: Endoscopy; Procedure: Biopsies taken

Placebo

PLACEBO COMPARATOR

Medium chain triglycerides 2 capsules twice daily for six months. Endoscopy and biopsies taken as described under intervention.

Procedure: Endoscopy; Procedure: Biopsies taken; Drug: Placebo

Interventions

Eicosapentanoic Acid (EPA) DRUG

2 x 500mg EPA capsules twice daily for 6 months

Also known as: ALFA

2g/day Eicosapentanoic Acid (EPA)

Endoscopy PROCEDURE

Endoscopy with video and photographs at baseline and month 6.

Also known as: Endoscopy either Colonoscopy or Flexible sigmoidoscopy.

2g/day Eicosapentanoic Acid (EPA); Placebo

Biopsies taken PROCEDURE

9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).

2g/day Eicosapentanoic Acid (EPA); Placebo

Placebo DRUG

2 x 500mg placebo capsules twice daily for 6 months

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have a known diagnosis of Familial Adenomatous Polyposis (FAP) and have had a previous colectomy with ileo-rectal anastomosis.
• Males or females aged 18 and over
• If the participant is female and of child bearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception (e.g. abstinence, condom, Intra-uterine device (IUD), birth control pill, diaphragm and spermicidal gel combination) since her last menses and will use adequate contraception during the study, is not lactating, and agrees to undergo a serum pregnancy test at baseline and month 6. Sexually active males must agree to use an accepted method of contraception.
• Rectal polyp status: the subject has an endoscopically assessable rectal segment.
• Subjects must show a willingness to abstain from regular use of non-steroidal anti-inflammatory medication for the duration of the study. A cardioprotective dose of aspirin (75mg) will be permitted.
• Subjects must have provided written informed consent to participate.
• Subjects must have assessable rectal polyps post baseline flexible sigmoidoscopy.
• Subjects must have the following rectal polyp burden at the conclusion of the baseline endoscopy:
• Rectum - 3 or more quantifiable polyps ≥2mm diameter
• In the rectum quantifiable polyps are defined as being within a composite "cloverleaf" photograph that includes a tattoo.

You may not qualify if:

• Subjects who are due to undergo an anticipated colectomy within 8 months of randomisation
• History of invasive carcinoma in the past 5 years other than resected Dukes' A/B1 colon cancer or resected non-melanomatous skin cancer
• Partial or complete colectomy within 12 months prior to enrolment.
• History of pelvic radiation
• Subjects who are allergic to fish
• Subjects who have diabetes mellitus
• Subjects who are pregnant or breast-feeding
• Subjects taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis other than low dose (75 mg) cardioprotective dose.
• Subjects who have aspirin-sensitive asthma
• Subjects suffering from haemorrhagic disorders
• Subjects who are taking warfarin or other anticoagulants
• Subjects who have significant abnormalities on their screening blood tests
• Subjects taking lipid lowering medication
• Subjects with gastrointestinal malabsorptive disease
• Subjects with known or prior coagulopathy

Sponsors & Collaborators

• S.L.A. Pharma AG: lead

Study Sites (1)

The Polyposis Registry, St. Mark's Hospital,

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Related Publications (1)

• West NJ, Clark SK, Phillips RK, Hutchinson JM, Leicester RJ, Belluzzi A, Hull MA. Eicosapentaenoic acid reduces rectal polyp number and size in familial adenomatous polyposis. Gut. 2010 Jul;59(7):918-25. doi: 10.1136/gut.2009.200642. Epub 2010 Mar 26.

  PMID: 20348368 DERIVED

MeSH Terms

Conditions

Adenomatous Polyposis Coli; Hyperplasia; Polyps

Interventions

Eicosapentaenoic Acid; Endoscopy

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr Chris Jordan
• Organization: S.L.A. Pharma (UK) Ltd

cjordan@slapharma.com

+44 (0)1923 681001

Study Officials

• Nicholas J West, MB BS FRCS

  The Polyposis Registry, St. Mark's Hospital,

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: August 2, 2007
• Study Start: November 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: August 22, 2014
• Results First Posted: August 22, 2014

Record last verified: 2014-08

Locations

GB (1)