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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Hepatocellular Carcinoma, Cholangiocarcinoma

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Trial Information

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


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- missing or withdrawn consent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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Matthias Pirlich, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Germany: Ethics Commission

Study ID:

EA1/174/05

NCT ID:

NCT00168987

Start Date:

January 2005

Completion Date:

June 2007

Related Keywords:

  • Colorectal Neoplasms
  • Hepatocellular Carcinoma
  • Cholangiocarcinoma
  • oral nutritional supplement
  • eicosapentanoic acid
  • gastroenterological tumors
  • muscle function
  • quality of life
  • body composition
  • Neoplasms
  • Carcinoma
  • Colorectal Neoplasms
  • Malnutrition
  • Cholangiocarcinoma
  • Carcinoma, Hepatocellular

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