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
Pilot Study: Randomized Controlled Trial on the 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
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.
improvement of muscle function (hand grip strength, respiratory muscle function) at two months
tolerance of the oral nutritional supplement
oral nutritional supplement rich in eicosapentanoic acid
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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 3 months - missing or withdrawn consent - simultaneous participation in another trial
18 Years - N/A
Accepts Healthy Volunteers
Matthias Pirlich, MD, ,
Charite University, Berlin, Germany
Pfrimmer Nutricia GmbH, Erlangen , Germany
Matthias Pirlich, MD, Principal Investigator, Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology