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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-06-30

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.

Detailed Description

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Conditions

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Colorectal Neoplasms Hepatocellular Carcinoma Cholangiocarcinoma

Keywords

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oral nutritional supplement eicosapentanoic acid gastroenterological tumors muscle function quality of life body composition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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oral nutritional supplement rich in eicosapentanoic acid

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Charite University, Berlin, Germany

Principal Investigators

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Matthias Pirlich, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology

Locations

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Charite University Hospital

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EA1/174/05

Identifier Type: -

Identifier Source: org_study_id