NCT00942292 — The Effect of Fish Oils on Human Hepatic Colorectal Metastases · CancerIndex
Clinical trial · Interventional
The Effect of Fish Oils on Human Hepatic Colorectal Metastases
Randomised Controlled Trial of the Effects of Fish Oil Emulsion in Total Parenteral Nutrition Upon Tumour Vascularity in Patients With Hepatic Colorectal Metastases
The purpose of this study is to determine whether fish oils - a known source of omega-3 given intravenously (via a 'drip') will help cure secondary deposits in the liver from bowel cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Colorectal Liver Metastases
—
UNRESOLVED
—
Interventions
Interventions (2)
Intervention
Type
Mapped drug
Match
Digital Contrast MRI scan
Procedure
—
UNRESOLVED
Lipidem- fish oil emulsion BBraun UK
Dietary Supplement
—
UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
ACTIVE_COMPARATOR
label
Lipidem (fish oil)
description
Lipidem (TPN containing fish oil)
interventionNames
Dietary Supplement: Lipidem- fish oil emulsion BBraun UK
Procedure: Digital Contrast MRI scan
type
ACTIVE_COMPARATOR
label
Lipofundin (TPN)
description
Control arm (no fish oil)
interventionNames
Dietary Supplement: Lipidem- fish oil emulsion BBraun UK
Procedure: Digital Contrast MRI scan
Primary outcomes (1)
measure
Change in gadolinium chelate enhancement on DCE-MRI between study entry and exit, as determined by calculating the bi-directional transfer co-efficient.(Changes in tumour angiogenesis after treatment with fish oils or control TPN)
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Maximum age
80 Years
Show eligibility criteria text
Inclusion Criteria:
1. Aged 18-80
2. Able to give informed written consent
3. Diagnosis of respectable hepatic colorectal metastases on radiological and laparoscopic appearances
Exclusion Criteria:
1. Patients already taking fish oil supplements
2. Hypersensitivity to fish-, egg-, or soy protein, or to any of the active substances or constituents in the lipid emulsion
3. Hyperlipidaemia
4. Severe blood coagulation disorders
5. Severe renal insufficiency (Creatinine \>200)
6. Any general contra-indications to infusion therapy - pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
7. Any unstable medical conditions - uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis
8. Patients undergoing conventional neo-adjuvant chemotherapy.
References
Publications (59)
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timeFrame
72 hours
Secondary outcomes (1)
measure
Changes in biomarkers of inflammation and angiogenesis in the patient's blood and resected tumour samples
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