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 anticatabolically 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.

Condition	Intervention	Phase
Colorectal Neoplasms Hepatocellular Carcinoma Cholangiocarcinoma	Drug: oral nutritional supplement rich in eicosapentanoic acid	Phase IV

Further Study Details: 

Primary Outcomes: - improvement of muscle function (hand grip strength, respiratory muscle function) at two months; - improvement of cognitive function at two months; - improvement of quality of liefe at two months
Secondary Outcomes: - tolerance of the oral nutrtional supplement; - improvement of nutrtional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)
Expected Total Enrollment:  30

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• malignant disease: colorectal neoplasm, hepatocellular carcinoma, cholangiocarcinoma
• palliative treatment of malignant disease: UICC stage >1
• impaired nutrtional 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 nutrtion (i.e. ileus, uncontrollable vomiting)
• terminal stage of disease with a life expectancy < 3 months
• missing or withdrawn consent
• simultaneous participation in another trial

Please refer to this study by ClinicalTrials.gov identifier  NCT00168987

Matthias Pirlich, MD      **49-30-450614062    matthias.pirlich@charite.de
Tatjana Schuetz, PhD      **49-30-450514059    elke-tatjana.schuetz@charite.de

Germany
      Charite University Hospital, Berlin,  10117,  Germany

Study chairs or principal investigators

Matthias Pirlich, MD,  Principal Investigator,  Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology   

Study ID Numbers:  EA1/174/05
Last Updated:  September 14, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00168987
Health Authority: Germany: Ethics Committee of Charite University Hospital
ClinicalTrials.gov processed this record on 2005-09-20