None listed
Conditions
Brief summary
Fish oils containing eicosapentaenoic acid (EPA) have been shown to prevent and reverse cancer-induced weight loss and cachexia by maintaining lean body mass. However, there have not been direct measurements of the components of weight loss nor the changes in body composition during and after the reversal. In addition, the reversal of weight loss and cachexia has not been investigated in patients with pancreatic cancer during chemotherapy. The RNS Hospital has the unique facilities to be able to directly, accurately and non-invasively measure these changes. We believe that the positive effects of EPA during chemotherapy will reduce weight loss, improve the quality of life as well as reducing chemotherapy-induced toxicities.
Interventions
This is a double-blind, randomised, placebo controlled clinical trial. All patients will be receiving the same standard chemotherapy regimen of Gemcitabine (1000mg/m2 iv D1, 8, 15, Q4 weekly). Treatment/placebo administration will be carried out during the first 16 weeks of the chemotherapy.
Body composition measurements, anthropometry and QL measurements will be carried out prior to chemotherapy and then at 4, 8, 12 and 16 weeks post-chemotherapy.
Sponsors
Professor Ross C Smith
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Patients with a pathologic diagnosis of pancreas cancer that is locally advanced and unresectable, partially resected or metastatic;2.Signed informed consent.3.Patients with the ability to understand the nature of the project and to provide informed consent;4.Patients with ECOG performance status of less than or equal to 2, as determined by the referring physician;5.Patients who are greater than 4 weeks post-operative or post radiotherapy.6.Adequate haematologic and biochemical functioning, including liver function tests, permitting suitability for Gemcitabine chemotherapy.7.Life expectancy of 12 weeks.8.Ability to complete the scheduled body composition measures.9.Ability to complete the QL questionnaire.
Exclusion criteria
1.Patients who have received and/or are receiving chemotherapy for pancreatic cancer;2.Progressing or untreated brain metastases.3.Pregnant and lactating women;4.Serious intercurrent medical illness or psychological, familial, sociological, geographical, or other concomitant conditions that do not permit adequate follow-up and compliance with the study protocol.5.Participation in clinical trials of other experimental agents within 30 days of study entry.6.Pregnant or lactating women or women of childbearing potential not using effective contraception.7.Radiotherapy within 4 weeks.8.Surgery within 6 weeks.Both male and female patients will be recruited for this trial.
Outcome results
None listed