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NCT Number: 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

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.

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Key information

Conditions

Colorectal Neoplasms Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charite University Hospital

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • missing or withdrawn consent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

Treatment and study plan

oral nutritional supplement rich in eicosapentanoic acid

Drug

Primary outcomes

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

  2. improvement of cognitive function at two months

  3. improvement of quality of life at two months

Secondary outcomes

  1. tolerance of the oral nutritional supplement

  2. improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Pfrimmer Nutricia GmbH, Erlangen , Germany

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
May 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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