A Study of the Effect of Gemcitabine With Fish Oil in Patients With Advanced Pancreatic Cancer

December 3, 2014 updated by: University Hospitals, Leicester

Phase II Trial of the Effect of Gemcitabine With Intravenous Omega-3 Fish Oil Infusion in Patients With Unresectable Pancreatic Adenocarcinoma

Over 7000 patients are diagnosed with pancreas cancer every year in the UK. Only 10% have it caught early enough to have surgery to cure it. The rest at best can undergo chemotherapy to extend survival, but current treatments offer at best an improvement of only a few months compared to no treatment at all. In addition only about a quarter of patients will respond to the treatment. In addition these patients often experience profound weight loss, loss of appetite and energy primarily because of the cancer process itself. Our hypothesis is that the addition of fish oil infusion to gemcitabine chemotherapy will result in an improved rate of tumour response on CT imaging.

Fish oils, or specifically the omega-3 fatty acid component, appear to have a range of powerful anti-cancer actions. This is supported by evidence from a wide range of sources, from laboratory experiments to basic human studies. Although this evidence specifically includes many pancreatic cancer studies in the laboratory it has not yet been confirmed in human trials.

Contrary to conventional chemotherapy, fish oil is a naturally occuring non-toxic compound and so is not associated with the side-effects of chemotherapy. In fact a number of clinical studies have demonstrated significant improvements in quality of life for pancreas cancer patients treated with fish oil, particularly with reference to improvements in appetite and energy levels. This is of course in addition to the anti-cancer actions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our trial will involve recruiting patients who have unresectable pancreatic cancer and who are suitable for the current standard of care which is gemcitabine chemotherapy. They will be assessed for suitability and then offered entry into the trial. This essentially consists of a 4 hour long infusion of purified omega-3 fish oil immediately after their gemcitabine chemotherapy has finished. This will occur once a week for three weeks, with a rest on the fourth week. The cycle then continues until the cancer has shown progression on a CT scan, the gemcitabine chemotherapy is stopped due to toxicity or the patient withdraws or dies. CT scans to assess this are performed every 2 months. Blood tests will be taken before and after each treatment and analysed for changes in inflammatory markers. The patients will be asked to fill in a quality of life and pain questionnaire each week during the 4 hour infusion.

Study Type

Interventional

Enrollment (Actual)

50

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, LE1 5WW
        • University Hospitals of Leicester : Leicester Royal Infirmary

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged >18 years
  • Able to give informed written consent
  • ECOG performance status of 0 or 1 (Appendix 1)
  • Life expectancy >12 weeks
  • Adequate hepatic and renal function documented within 14 days prior to treatment AST and ALT ≤2.5x upper limit of normal (ULN), unless liver metastases present, in which case ≤5.0xULN Total bilirubin ≤2.5xULN Serum creatinine ≤1.5xULN or calculated creatinine clearance ≥60ml/min Urinary protein <1+ by urine dipstick. If ≥1+, then 24-hour urine collection should be done and may only be enrolled if urine protein is <2g/24hours
  • Adequate bone marrow function Haemoglobin ≥9g/dL (can have transfusion or growth factors) Platelets ≥100,000cells/mm3 Neutrophil count ≥1500cells/mm3
  • No significant hyperlipidaemia
  • Patients without severe blood coagulation disorders (anticoagulants allowed)
  • Women of childbearing age must have a negative pregnancy test (urine or serum) at commencement of treatment
  • Willingness to comply with scheduled visits, treatment, laboratory test, and other aspects of the trial

Exclusion Criteria:

  • Prior treatment with any systemic chemotherapy for metastatic disease
  • Prior adjuvant radio- or chemotherapy within 4 weeks of starting the study
  • Previous treatment with gemcitabine
  • Hypersensitivity to fish-, egg-, or soy protein, or to any of the active substances or constituents in the lipid emulsion
  • 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
  • Known HIV or AIDS
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with requirements of the protocol
  • History of malignancy other than pancreatic cancer, with the exception of curative treatment for skin cancer (other than melanoma) or in situ breast or cervical carcinoma, or those treated with curative intent for any other cancer with no evidence of disease for 5 years
  • Major surgical procedure or significant traumatic injury within 4 weeks of treatment
  • Female patients must be surgically sterilised or postmenopausal or agree to use two adequate contraception measures during the period of therapy and continued for 6 months after the last dose of gemcitabine. Male patients must be surgically sterilised or agree to use adequate contraception for the same period.
  • Patients deemed unsuitable for gemcitabine 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients
All patients entering the trial
Drug: Lipidem fish oil infusion + Gemcitabine chemotherapy
500mls intravenous infusion once a week of lipidem in addition to standard starting dose of gemcitabine (1000mg/m2) Dose can be reduced if poorly tolerated
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (complete and partial response) on CT according to RECIST criteria
Time Frame: Every 2 months
Every 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: measured once for each patient
measured once for each patient
Progression free survival
Time Frame: Measured once for each patient
Measured once for each patient
Safety / tolerability of fish oil and gemcitabine
Time Frame: weekly
weekly
Quality of life scores
Time Frame: weekly
weekly
brief pain inventory scores
Time Frame: weekly
weekly
Pharmacokinetic analysis of blood samples
Time Frame: weekly (before and after treatment)
weekly (before and after treatment)

Collaborators and Investigators

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

Sponsor

University Hospitals, Leicester

Collaborators

B. Braun Medical Inc.

Investigators

  • Principal Investigator: Ashley Dennison, MD FRCS, University Hospitals, Leicester
  • Study Director: William Steward, Phd FRCP, University Hospitals, Leicester
  • Study Chair: Matthew Metcalfe, MA MD FRCS, University Hospitals, Leicester

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

October 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/H0408/51
  • EudraCT number 2009-009470027
  • UHL trial number 10720

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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