Clinical trial NCT00168987: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Neoplasms
Hepatocellular Carcinoma
Cholangiocarcinoma
Keywords: oral nutritional supplement
eicosapentanoic acid
gastroenterological tumors
muscle function
quality of life
body composition
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Pfrimmer Nutricia GmbH, Erlangen , Germany
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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* missing or withdrawn consent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

Primary outcomes:
measure: improvement of muscle function (hand grip strength, respiratory muscle function) at two months
measure: improvement of cognitive function at two months
measure: improvement of quality of life at two months
Secondary outcomes:
measure: tolerance of the oral nutritional supplement
measure: improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Hospital
Study officials:
affiliation: Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology
name: Matthias Pirlich, MD
role: PRINCIPAL_INVESTIGATOR
References: