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

Phase 4

Completed

• Conditions: Colorectal Neoplasms; Hepatocellular Carcinoma; Cholangiocarcinoma

• Registration Number: NCT00168987
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-15
• Primary Completion: 2006-11
• Study Completion: 2007-06
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-05
• Last Update Posted: 2008-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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• missing or withdrawn consent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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
tolerance of the oral nutritional supplement
improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)

Trial Locations

Locations (1)

Charite University Hospital; 🇩🇪 Berlin, Germany