C25 R64
Conditions
Interventions
Group 1: Dietary supplementation with marine phospholipids (MPL), as softgelatine capsules (500mg)
Application: 3 times daily one capsule together with meals (1.5 g/d) for a period of six weeks
Group
Sponsors
Internationales Pankreaskarzinomzentrum
an der Abteilung für Allgemein- und Viszeralchirurgie
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight loss (daily measurement by the patient himself for a period of six weeks, documentation in patient diary) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactKristin;Andrea Werner;Lubitz
Internationales Pankreaskarzinomzentrum an der Klinik für Tumorbiologie;Internationales Pankreaskarzinomzentrum an der Abteilung für Allgemein- und Viszeralchirurgie Universitätsklinikum Freiburg
Outcome results
None listed