Trial document




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  DRKS00000345

Trial Description

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Title

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

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Trial Acronym

Phosfood II

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URL of the Trial

http://www.pankreas-karzinom-zentrum.de/neue-therapieverfahren/klinische-studien-pankreas.php

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Brief Summary in Lay Language

Most patients with pancreatic cancer (up to 80 %) suffer from a severe, tumour-associated weight loss which strongly impairs quality of life, life expectancy as well as therapeutic options. Aim of the study is to evaluate the effects of phospholipids with a high percentage of omega-3 fatty acids (marine phospholipids from salmon roe, MPL) on weight loss, appetite and quality of life of patients with pancreatic cancer. The anti-inflammatory omega-3 fatty acids applied as phospholipids are expected to be taken up more efficiently by tumour cells than the same fatty acids applied as triglycerides (fish oil).
To investigate the effect of MPL on weight loss, appetite and quality of life 80 patients with pancreatic cancer (40 post-surgical and 40 receiving palliative treatment) will receive 1.5 g MPL daily for six weeks, or, as control, a fish oil formulation containing the same amount and compostion of omega-3 fatty acids in identical capsules.

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Brief Summary in Scientific Language

Cancer cachexia is a special case of malnutrition which occurs in up to 80 % of patients suffering from pancreatic cancer and is associated with a systemic inflammatory reaction. Cancer cachexia mostly occurs in advanced disease, often accompanied by loss of appetite, and impairs quality fo life as well as life expectancy.
The underlying systemic inflammatory reaction involves fatty acid metabolism. Cytokines like IL-1, IL-6 and TNFalpha induce the activity of phospholipases A2 which cleaves, among others, the n-6 FA arachidonic acid (AA) out of membrane phospholipids. AA is further processed by COX enzymes to pro-inflammatory eicosanoids which mediate cachexia in pancreatic cancer.
N-3 FA compete with AA for the bound position in membrane phospholipids as well as the processing by COX. N-3 FA are processed mainly into anti-inflammatory eicosanoids. An enrichment of n-3 FA in cellular membranes can therefore reduce pro-inflammatory eicosanoids.
N-3 FA given orally as phospholipids are metabolised differently than triglycerides. In vitro studies with solid tumour cell lines have shown the uptake of phospholipids causing the desired change of fatty acid composition in the cellular membrane.
Aim of this study is therefore to investigate the effect of marine Phospholipids (MPL) on weight loss, appetite and quality of life compared to fish oil. 80 patients with pancreatic cancer (40 post-surgical, 40 palliative) will receive 1.5 g MPL or fishoil with similar fatty acid composition daily for six weeks. Allocation to treatment groups will carried out stratified, randomised and double blind.

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Organizational Data

  •   DRKS00000345
  •   2010/03/08
  •   [---]*
  •   yes
  •   Approved
  •   25/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1113-6181 
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Health Condition or Problem studied

  •   C25 -  Malignant neoplasm of pancreas
  •   R64 -  Cachexia
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Interventions/Observational Groups

  •   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
  •   Dietary supplementation with fish oil in softgelatine capsules (500mg)
    Application: 3 times daily one capsule together with meals (1.5 g/d) for a period of six weeks
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   [---]*
  •   Active control
  •   Supportive care
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/02/24
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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 %

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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

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Addresses

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    • Internationales Pankreaskarzinomzentrum an der Abteilung für Allgemein- und Viszeralchirurgie Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med.  Tobias  Keck 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Internationales Pankreaskarzinomzentrum an der Klinik für Tumorbiologie
    • Mr.  Prof. Dr. rer. nat.  Ulrich  Massing 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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    • Internationales Pankreaskarzinomzentrum an der Klinik für Tumorbiologie
    • Ms.  Kristin  Werner 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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    • Internationales Pankreaskarzinomzentrum an der Abteilung für Allgemein- und Viszeralchirurgie Universitätsklinikum Freiburg
    • Ms.  Andrea  Lubitz 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Internationales Pankreaskarzinomzentrum Freiburg
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/02/23
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.