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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Neoplasms, Hepatocellular Carcinoma, Cholangiocarcinoma

Intervention / Treatment
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* Drug: oral nutritional supplement rich in eicosapentanoic acid


Participation Criteria
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Eligibility Criteria
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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 3 months missing or withdrawn consent simultaneous participation in another trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oral nutritional supplement rich in eicosapentanoic acid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerance of the oral nutritional supplement |  |  | 
| improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral nutritional supplement, eicosapentanoic acid, gastroenterological tumors, muscle function, quality of life, body composition