Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa

NCT00432913 | Completed Phase 2

• 1 other identifier: EPA/POL/02
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps.

Conditions

Adenomatous Polyps

Keywords

Eicosapentaenoic acid; EPA; EPA 99%; Fatty acid; omega-3; apoptosis; cell proliferation; colonic mucosa; polyps; adenomatous polyps; endoscopy; PUFA

Outcome Measures

Primary Outcomes (2)

• To measure levels of apoptosis in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.

  3 months and 6 months

• To measure levels of cell proliferation in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.

  3 months and 6 months

Secondary Outcomes (2)

• To measure the tissue content of EPA in the colonic mucosa before, during and after treatment with EPA.

  3 months and 6 months

• To determine the safety and tolerability of EPA.

  3 months and 6 months

Study Arms (3)

1g EPA per day

ACTIVE COMPARATOR

Drug: Eicosapentaenoic Acid (EPA); Procedure: Endoscopy; Procedure: Biopsies taken; Procedure: Clinical chemistry; Procedure: Haematology; Procedure: Physical examination; Procedure: Vital signs; Procedure: Urine pregnancy test; Procedure: Completion of patient diary card

2g EPA per day

ACTIVE COMPARATOR

Drug: Eicosapentaenoic Acid (EPA); Procedure: Endoscopy; Procedure: Biopsies taken; Procedure: Clinical chemistry; Procedure: Haematology; Procedure: Physical examination; Procedure: Vital signs; Procedure: Urine pregnancy test; Procedure: Completion of patient diary card

Placebo

PLACEBO COMPARATOR

Procedure: Endoscopy; Procedure: Biopsies taken; Procedure: Clinical chemistry; Procedure: Haematology; Procedure: Physical examination; Procedure: Vital signs; Procedure: Urine pregnancy test; Procedure: Completion of patient diary card

Interventions

Eicosapentaenoic Acid (EPA) DRUG

Either 2 x 500mg EPA capsules in the morning and evening (2g per day EPA) or 1 x 500mg EPA and 1 x placebo in the morning and evening (1g per day EPA)

Also known as: ALFA

1g EPA per day; 2g EPA per day

Endoscopy PROCEDURE

At baseline, month 3 and month 6.

Also known as: Colonoscopy, Flexible sigmoidoscopy

1g EPA per day; 2g EPA per day; Placebo

Biopsies taken PROCEDURE

9 biopsies taken for measurement of apoptosis (3 biopsies), cell proliferation (3 biopsies) and fatty acid levels (3 biopsies) at baseline, month 3 and month 6.

1g EPA per day; 2g EPA per day; Placebo

Clinical chemistry PROCEDURE

Full blood count at baseline, month 3 and month 6.

1g EPA per day; 2g EPA per day; Placebo

Haematology PROCEDURE

Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.

1g EPA per day; 2g EPA per day; Placebo

Physical examination PROCEDURE

Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.

1g EPA per day; 2g EPA per day; Placebo

Vital signs PROCEDURE

Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.

1g EPA per day; 2g EPA per day; Placebo

Urine pregnancy test PROCEDURE

For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.

1g EPA per day; 2g EPA per day; Placebo

Completion of patient diary card PROCEDURE

Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.

1g EPA per day; 2g EPA per day; Placebo

Eligibility Criteria

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

You may qualify if:

• Males or females aged over 18
• Patients of child-bearing potential must demonstrate a negative pregnancy test at screening, and should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:
• Oral contraceptive + condom
• Intra-uterine device (IUD)+ condom
• Diaphragm with spermicide + condom
• Male partners of women of child bearing potential should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:
• Oral contraceptive + condom
• Intra-uterine device (IUD)+ condom
• Diaphragm with spermicide + condom
• Patients must have a known history of colorectal adenomata and be under clinical follow-up for these, or be found to have one or more of these at the time of colonoscopy
• Patients must have provided written informed consent to participate

You may not qualify if:

• Patients who are allergic to fish
• Patients who have diabetes mellitus
• Patients who are pregnant or breast-feeding
• Patients taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis
• Patients who have aspirin-sensitive asthma
• Patients suffering from haemorrhagic disorders
• Patients who are taking warfarin or other anticoagulants
• Patients who have significant abnormalities on their screening blood tests
• Patients taking lipid lowering medication
• Patients with known inflammatory bowel disease (IBD), or previously unknown IBD until discovered at the time of their colonoscopy
• Patients with gastrointestinal malabsorptive disease
• Patients belonging to a known polyposis syndrome (e.g. FAP, HNPCC)
• Patients with a previous colonic resection for colorectal cancer
• Patients who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study
• Patients who are deemed mentally incompetent, or have a history of anorexia nervosa or bulimia

Sponsors & Collaborators

• S.L.A. Pharma AG: lead

Study Sites (2)

S. Orsola Hospital

Bologna, 40138, Italy

Location

St. George's Hospital Medical School

London, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Adenomatous Polyps; Hyperplasia; Polyps

Interventions

Eicosapentaenoic Acid; Endoscopy; Colonoscopy; Clinical Chemistry Tests; Restraint, Physical

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; 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; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures; Clinical Laboratory Techniques; Investigative Techniques; Behavior Control; Therapeutics; Immobilization

Study Officials

• Nicholas J West, MB BS FRCS

  St. George's Hospital Medical School, London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 8, 2007
• Study Start: October 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 17, 2008

Record last verified: 2008-10

Locations

GB (1); IT (1)