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

Primary Purpose

Adenomatous Polyps

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Eicosapentaenoic Acid (EPA)
Endoscopy
Biopsies taken
Clinical chemistry
Haematology
Physical examination
Vital signs
Urine pregnancy test
Completion of patient diary card
Sponsored by
S.L.A. Pharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomatous Polyps focused on measuring Eicosapentaenoic acid, EPA, EPA 99%, Fatty acid, omega-3, apoptosis, cell proliferation, colonic mucosa, polyps, adenomatous polyps, endoscopy, PUFA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients with a history of alcohol or drug abuse, including laxative abuse
  • Patients considered by their physician unlikely to be able to comply with the protocol.
  • Patients who have taken part in an experimental drug study in the preceding 2 months.

Sites / Locations

  • S. Orsola Hospital
  • St. George's Hospital Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1g EPA per day

2g EPA per day

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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%.
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%.

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2007
Last Updated
October 16, 2008
Sponsor
S.L.A. Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00432913
Brief Title
Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa
Official Title
The Effect of Two Dose Levels of Eicosapentaenoic Acid (EPA) on Apoptosis and Cell Proliferation in the Colonic Mucosa of Patients With a History of Colonic Polyps.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
S.L.A. Pharma AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Colorectal cancer is generally accepted to develop from changes within colonic adenomatous polyps. More than 90% of new large bowel cancers arise sporadically. The molecular events leading to the development of colorectal cancer from polyps are characterised by an imbalance in cell proliferation (formation of new cells) and apoptosis (natural cell death) from changes in the genes involved in normal colon cells. Recent work at St George's Hospital Medical School, London, has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified, free-fatty acid form of eicosapentaenoic acid (EPA). Comparator(s): 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps
Keywords
Eicosapentaenoic acid, EPA, EPA 99%, Fatty acid, omega-3, apoptosis, cell proliferation, colonic mucosa, polyps, adenomatous polyps, endoscopy, PUFA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1g EPA per day
Arm Type
Active Comparator
Arm Title
2g EPA per day
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Eicosapentaenoic Acid (EPA)
Other Intervention Name(s)
ALFA
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Endoscopy
Other Intervention Name(s)
Colonoscopy, Flexible sigmoidoscopy
Intervention Description
At baseline, month 3 and month 6.
Intervention Type
Procedure
Intervention Name(s)
Biopsies taken
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Clinical chemistry
Intervention Description
Full blood count at baseline, month 3 and month 6.
Intervention Type
Procedure
Intervention Name(s)
Haematology
Intervention Description
Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
Intervention Type
Procedure
Intervention Name(s)
Physical examination
Intervention Description
Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
Intervention Type
Procedure
Intervention Name(s)
Vital signs
Intervention Description
Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
Intervention Type
Procedure
Intervention Name(s)
Urine pregnancy test
Intervention Description
For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
Intervention Type
Procedure
Intervention Name(s)
Completion of patient diary card
Intervention Description
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.
Primary Outcome Measure Information:
Title
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%.
Time Frame
3 months and 6 months
Title
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%.
Time Frame
3 months and 6 months
Secondary Outcome Measure Information:
Title
To measure the tissue content of EPA in the colonic mucosa before, during and after treatment with EPA.
Time Frame
3 months and 6 months
Title
To determine the safety and tolerability of EPA.
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Patients with a history of alcohol or drug abuse, including laxative abuse Patients considered by their physician unlikely to be able to comply with the protocol. Patients who have taken part in an experimental drug study in the preceding 2 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas J West, MB BS FRCS
Organizational Affiliation
St. George's Hospital Medical School, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
S. Orsola Hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
St. George's Hospital Medical School
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

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

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