Effects of fish oil containing eicosapentaenoic acid (EPA) on weight loss and cachexia in pancreatic cancer patients undergoing cancer chemotherapy.

Recruiting

• Conditions: Weight loss.; Cachexia.; Pancreatic cancer chemotherapy.; Changes in body composition.; Cancer - Pancreatic

• Registration Number: ACTRN12607000323426
• Lead Sponsor: Professor Ross C Smith

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the trial is to assess the changes in body composition and the effects of EPA in pancreatic cancer patients undergoing cancer chemotherapy. It is hypothesised that the EPA will reduce weight loss and cachexia in this group of patients. [Body composition measurements will be carried out at 0 (baseline), 4, 8, 12, and 16 weeks post-chemotherapy to assess any changes in weight and the components of weight (ie fat, water, and protein).]

Secondary Outcome Measures

Name	Time	Method
The daily administration of EPA may also have possible improvement in Quality of Life and survival.[The quality of life is assessed using the EORTC QLQ-C30 and PAN-26 quality of life questionnaires at 0 (base-line), 4, 8, 12, and 16 weeks post-chemotherapy.];The daily administration of EPA may reduce chemotherapy-induced toxicities.[ Similarly, the chemotherapy induced toxicity (white blood cell and neutrophil counts) will be measured at 0 (base-line), 4, 8, 12, and 16 weeks post-chemotherapy.]