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Randomised Controlled Trial of the Effects of Fish Oil Emulsion in Total Parenteral Nutrition Upon Tumour Vascularity in Patients With Hepatic Colorectal Metastases

Phase 2
18 Years
80 Years
Not Enrolling
Colorectal Liver Metastases

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Trial Information

Randomised Controlled Trial of the Effects of Fish Oil Emulsion in Total Parenteral Nutrition Upon Tumour Vascularity in Patients With Hepatic Colorectal Metastases

Fish oils have many proven benefits for a wide range of clinical arenas such as ischaemic
heart disease, rheumatoid arthritis and inflammatory bowel disease.

Recent research has described the beneficial effects of intravenous fish oils for surgical
patients, such as reduced hospital stay, reduced re-operation rate and reduced requirements
for intravenous antibiotics. These are in part due to the anti-inflammatory effects of fish

There is evidence that fish oils are also effective against cancer, large population studies
indicate that diets rich in omega-3 are associated with a lower incidence of cancer, and in
vitro and animal studies demonstrate anti-tumour effects of fish oils

1. Fish oils inhibit the growth of different human cancer cell lines

2. They act specifically on tumour cells only and do not impair the function of normal

3. EPA and DHA inhibit the growth of human cancer cell lines and enhance apoptosis.

4. Fish oil induces apoptosis in human colorectal cancer cell lines in-vitro after 48hrs

5. Fish oil has been shown to inhibit the proliferation activities, inhibit the invasive
activities and increase the apoptosis of human pancreatic carcinoma cell lines in-vitro
after only 48hrs of exposure

6. Fish oil has been shown to enhance colorectal adenocarcinoma cell lines sensitivity to

7. Fish oil has also been shown to reduce the incidence of liver metastases in
experimentally induced ductal pancreatic cancer in rats after 30 weeks of oral
treatment with an omega-3 supplemented diet.

8. Lung cancer xenografts in animals fed with fish oil showed significantly increased
tumour regression in response to doxorubicin compared to those fed with omega-3.

This study aims to assess the effect of omega-3 FA upon hepatic colorectal metastases in a
pilot study. 20 patients will be selected for this pilot study with potentially resectable
hepatic colorectal adenocarcinoma metastases. 10 patients will receive total parenteral
nutrition (TPN) without fish oils (controls), 10 will receive fish oil containing lipid
emulsion in their TPN.

Changes in tumour angiogenesis (increased angiogenesis is associated with a poorer prognosis
in hepatic colorectal metastases) will be investigated using digital contrast enhanced MRI
scanning, and markers of angiogenesis will be investigated in blood and resected tumour
samples from the patients.

It is a randomised controlled double blind trial.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome 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)

Outcome Time Frame:

72 hours

Safety Issue:


Principal Investigator

Ashley R Dennison, MBChB, FRCS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Leicester General Hospital


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2007

Completion Date:

October 2010

Related Keywords:

  • Colorectal Liver Metastases
  • Hepatic
  • colorectal
  • metastases
  • TPN
  • Fish oil
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms