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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S.L.A. Pharma AG

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Subjects with uncontrolled hypercholesterolaemia

• Subjects who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. Subjects previously taking fish oil must have a washout period of 1 month prior to study enrolment.

• Subjects who are deemed mentally incompetent, or have a history of anorexia nervosa or bulimia

• Subjects with a history of alcohol or drug abuse, including laxative abuse which would render the subject unreliable.

• Subjects considered by their physician unlikely to be able to comply with the protocol.

• Subjects who have taken part in an experimental drug study in the preceding 3 months.

• Subjects who have a positive pregnancy test within 14 days prior to baseline visit.