Randomised controlled trial of the effects of fish oil emulsion in total parenteral nutrition upon tumour vascularity in patients with hepatic colorectal metastases - OMEGA-3 FATTY ACIDS AND HEPATIC COLORECTAL METASTASES

Phase 1

• Conditions: Potentially resectable hepatic (liver) metastases from colorectal (bowel) cancer.

• Registration Number: EUCTR2006-000044-71-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust Research & Development Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-11
• Study Completion: 2009-10-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patients with hepatic colorectal metastases, in whom the disease is assessed as amenable to curative resection will be eligible for the study. The inclusion criteria will be:
·Aged 18-80
·Able to give informed written consent
·Diagnosis of respectable hepatic colorectal metastases on radiological and laparoscopic appearances

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

Patients will be excluded from this trial if they have:
·Hypersensitivity to fish-, egg-, or soy protein, or to any of the active substances or constituents in the lipid emulsion
·Hyperlipidaemia
·Severe blood coagulation disorders
·Severe renal insufficiency (Creatinine >200)
·Any general contra-indications to infusion therapy – pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
·Any unstable medical conditions – uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis
·Patients undergoing conventional neo-adjuvant chemotherapy
. Cardiac pacemaker or any other ferromagnetic implant not authorised for use in MRI

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified