Overview

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

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
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 anticatabolic acting substrate in cancer patients. Only few randomized trials are available which investigated the effect of EPA in form of an EPA-enriched, protein- and energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma. Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional state and quality of life in patients with other gastroenterological tumors and weight loss is investigated in this randomized prospective trial.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Charite University, Berlin, Germany
Collaborator:
Pfrimmer Nutricia GmbH, Erlangen , Germany
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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- missing or withdrawn consent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