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

Charite University, Berlin, Germany30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Neoplasms Hepatocellular Carcinoma Cholangiocarcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 3 months * missing or withdrawn consent * simultaneous participation in another trial

Outcomes

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 life at two months

Secondary Outcomes

tolerance of the oral nutritional supplement

improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)