Cholangiocarcinoma, Colorectal Neoplasms, Hepatocellular Carcinoma
Conditions
Keywords
oral nutritional supplement, eicosapentanoic acid, gastroenterological tumors, muscle function, quality of life, body composition
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 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.
Interventions
DRUGoral nutritional supplement rich in eicosapentanoic acid
Sponsors
Pfrimmer Nutricia GmbH, Erlangen , Germany
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 3 months * missing or withdrawn consent * simultaneous participation in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement of muscle function (hand grip strength, respiratory muscle function) at two months | — |
| improvement of cognitive function at two months | — |
| improvement of quality of life at two months | — |
Secondary
| Measure | Time frame |
|---|---|
| tolerance of the oral nutritional supplement | — |
| improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin) | — |
Countries
Germany
Outcome results
None listed