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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1g EPA per day | Active Comparator |
| |
| 2g EPA per day | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas J West, MB BS FRCS | St. George's Hospital Medical School, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Orsola Hospital | Bologna | 40138 | Italy | |||
| St. George's Hospital Medical School |
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|
| Endoscopy | Procedure | At baseline, month 3 and month 6. |
|
|
| 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. |
|
| Clinical chemistry | Procedure | Full blood count at baseline, month 3 and month 6. |
|
| Haematology | Procedure | Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6. |
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| Physical examination | Procedure | Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6. |
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| Vital signs | Procedure | Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6. |
|
| Urine pregnancy test | Procedure | For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6. |
|
| 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. |
|
| London |
| SW17 0RE |
| United Kingdom |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D006965 | Hyperplasia |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| D004724 | Endoscopy |
| D003113 | Colonoscopy |
| D019963 | Clinical Chemistry Tests |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D013505 | Digestive System Surgical Procedures |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
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