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

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Brief Title

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

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

improvement of muscle function (hand grip strength, respiratory muscle function) at two months

Secondary Outcome

 tolerance of the oral nutritional supplement

Condition

Colorectal Neoplasms

Intervention

oral nutritional supplement rich in eicosapentanoic acid

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

30

Start Date

January 2005

Completion Date

June 2007

Primary Completion Date

November 2006

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Matthias Pirlich, MD, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00168987

Organization ID

EA1/174/05

Study Sponsor

Charite University, Berlin, Germany

Collaborators

 Pfrimmer Nutricia GmbH, Erlangen , Germany

Study Sponsor

Matthias Pirlich, MD, Principal Investigator, Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology

Verification Date

May 2008