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

This study has been completed.
Sponsor:
Collaborator:
Pfrimmer Nutricia GmbH, Erlangen , Germany
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00168987
First received: September 13, 2005
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Colorectal Neoplasms
Hepatocellular Carcinoma
Cholangiocarcinoma
Drug: oral nutritional supplement rich in eicosapentanoic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

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)

Estimated Enrollment: 30
Study Start Date: January 2005
Study Completion Date: June 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168987

Locations
Germany
Charite University Hospital
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Pfrimmer Nutricia GmbH, Erlangen , Germany
Investigators
Principal Investigator: Matthias Pirlich, MD Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology
  More Information

No publications provided

Responsible Party: Dr. Matthias Pirlich, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00168987     History of Changes
Other Study ID Numbers: EA1/174/05
Study First Received: September 13, 2005
Last Updated: May 5, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
oral nutritional supplement
eicosapentanoic acid
gastroenterological tumors
muscle function
quality of life
body composition

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Colorectal Neoplasms
Nutrition Disorders
Malnutrition
Cholangiocarcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma
Liver Neoplasms
Liver Diseases

ClinicalTrials.gov processed this record on September 14, 2014