Barrett's oesophagus refers to changes in the lining of the lower oesophagus in response to injury caused by gastric reflux. It is a pre-malignant condition and has a well established link with adenocarcinoma of the oesophagus which is increasing in frequency in western countries. Although not everyone will progress to cancer, there is as yet no established medical therapy which will reverse the process. MedDRA version: 9.1 Level: LLT Classific
Conditions
Interventions
Product Name: Eicosapentanoic acid, free fatty acid
Product Code: EPA 99%
Pharmaceutical Form: Capsule, soft
Sponsors
St George's Healthcare NHS Trust
SLA Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any patient, male or female, aged 18+ undergoing endoscopic surveillance for Barrett's oesophagus. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: . Patients who are allergic to fish (cannot take tablets) · Pregnant or breast-feeding patients (although there is no known harm associated with the capsules we are not keen to give them to pregnant people in case of unknown harmful effects) . Patients with a bleeding diathesis/disorder · Patients who are taking warfarin or other anticoagulants (excluding aspirin) - (EPA can interact with warfarin and increase bleeding risk) . Patients with known gastrointestinal malabsorption · Patients with known dysplasia at previous endoscopy · Patients who are taking other fish-oil supplements (eg cod liver oil) who are unwilling to stop them for the duration of the study · Patients deemed mentally incompetent. · Patients considered by their physician unlikely to be able to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Polyunsaturated omega 3 fatty acids (PUFA) found in fish oils have been shown to be of benefit in certain conditions, for example cardiovascular disease and colorectal cancer.We are investigating the effect of such a PUFA, specifically eicosanopentanoic acid (EPA), on Barrett's oesophagus and its effects on progression of dysplasia a precursor to malignancy. ;Secondary Objective: ; Primary end point(s): This is a pilot study looking at the effects of EPA on Barrett cell apoptosis (programmed cell death), abnormal cell proliferation and levels of the enzyme ornithine decarboxylase which are markers of progression to Barrett cell dysplasia, a precursor of malignancy We will use three laboratory 'markers' which have been shown to be altered in Barrett's oesophagus and cancer in general. Apoptosis or programmed cell death is a process whereby cells die as part of their normal function. Apoptosis has been shown to be reduced in cancers, including that of the oesophagus. Abnormal cellular proliferation may play a role in the development of abnormal cells, and it has been shown previously that using the antibody we will be using,(Ki-67), the proliferation is higher in Barrett's with dysplasia and cancer than in Barrett's without these changes. Finally the level of an enzyme called ornithine decarboxylase has been shown to be higher in those Barrett's patients who have dysplasia than those without. The aim of this study is to treat patients with EPA and measure these 3 parameters to test the hypothesis that EPA influences these 3 markers favourably and may therefore represent a novel therapy to reduce the risk of a patient with Barrett's oesophagus developing cancer of the oesophagus. | — |
Countries
United Kingdom
Outcome results
None listed