Dietary supplementation with omega-3-fatty acids in patients with pancreatic cancer and weight loss: marine phospholipids versus fish oil

Not Applicable

• Conditions: C25; R64; Malignant neoplasm of pancreas; Cachexia

• Registration Number: DRKS00000345
• Lead Sponsor: Internationales Pankreaskarzinomzentruman der Abteilung für Allgemein- und ViszeralchirurgieUniversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-08
• Study Completion: 2011-02-23
• Results First Posted: 2017-06-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients suffering from pancreatic cancer who are under medical care of the International Pancreatic Cancer Center Freiburg:
o Post-surgical: Patients who underwent surgery at least 4 weeks ago and are back on normal nutrition
o Palliative: Patients who are either receiving chemotherapy or best supportive care
- age greater than/equal to 18 years
- Patients with a life expectancy of at least 3 months
- Written informed consent
- Patients with a weight loss greater than/equal to 5 % of body weight since first diagnosis
- Karnofsky index greater than/equal to 60 %

Exclusion Criteria

- Patients with a known allergy to fish or seafood
- Patients who cannot eat normally
- Patients with a weight loss greater than 15 % of total body weight since first diagnosis
- Patients with known disturbance of resorption which cannot be alleviated by enzyme substitution
- Patients suffering from disturbed coagulation
- Patients already taking Omega-3 formulations or other dietary supplements as well as pharmaceuticals which may influence the trial outcome
- Patients suffering from severe concomitant diseases
- Patients with psychiatric or neurological disorders which may impair ability to consent
- Patients already participating in other clinical trials

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
weight loss (daily measurement by the patient himself for a period of six weeks, documentation in patient diary)

Secondary Outcome Measures

Name	Time	Method
Quality of life (at the beginning and after six weeks participation with the EORTC QLQ C30 questionnaire plus the PAN26 module) || Appetite (daily documentation in patient diary for six weeks) || Blood parameters at the beginning and after six weeks: fatty acids in blood plasma, IL-6 concentration || nutritional status (fat and muscle mass) by measurement of upper arm circumference and skinfold thickness at 4 defined points at the beginning and after six weeks