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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT00168987

Collaborator

Pfrimmer Nutricia GmbH, Erlangen , Germany (Industry)

Enrollment

Location

28.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Hepatocellular Carcinoma Cholangiocarcinoma	Drug: oral nutritional supplement rich in eicosapentanoic acid	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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