Status:
COMPLETED
Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Pfrimmer Nutricia GmbH, Erlangen , Germany
Conditions:
Colorectal Neoplasms
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as specific and ant...
Eligibility Criteria
Inclusion
- malignant disease: colorectal neoplasm, hepatocellular carcinoma, cholangiocarcinoma
- palliative treatment of malignant disease: UICC stage \>1
- impaired nutritional state: weight loss \> 5% body weight in the preceding 6 months or subjective global assessment grade B (moderately malnourished) or grade C (severely malnourished)
- informed written consent
Exclusion
- age \< 18 years
- pregnancy
- exclusive enteral or parenteral nutrition
- taking of eicosapentanoic acid in form of fish oil capsules
- contraindications for oral nutrition (i.e. ileus, uncontrollable vomiting)
- terminal stage of disease with a life expectancy \< 3 months
- missing or withdrawn consent
- simultaneous participation in another trial
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00168987
Start Date
January 1 2005
End Date
June 1 2007
Last Update
May 9 2008
Active Locations (1)
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1
Charite University Hospital
Berlin, Germany, 10117