The Effect of Fish Oils on Human Hepatic Colorectal Metastases

June 24, 2013 updated by: University Hospitals, Leicester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 oils.

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 cells
  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 incubation
  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 radiotherapy
  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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Leicester General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lipidem (fish oil)
Lipidem (TPN containing fish oil)
Dietary supplement: Lipidem- fish oil emulsion BBraun UK
Procedure: Digital Contrast MRI scan
Active Comparator: Lipofundin (TPN)
Control arm (no fish oil)
Dietary supplement: Lipidem- fish oil emulsion BBraun UK
Procedure: Digital Contrast MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in biomarkers of inflammation and angiogenesis in the patient's blood and resected tumour samples
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Collaborators

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Ashley R Dennison, MBChB, FRCS, MD, Leicester General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

July 17, 2009

First Posted (Estimate)

July 20, 2009

Study Record Updates

Last Update Posted (Estimate)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10097 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • REC reference: 06/Q2501/160
  • EudraCT number: 2006-000044-71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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