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
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2005
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMay 9, 2008
May 1, 2008
1.8 years
September 13, 2005
May 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
tolerance of the oral nutritional supplement
improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite University Hospital
Berlin, 10117, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias Pirlich, MD
Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
January 1, 2005
Primary Completion
November 1, 2006
Study Completion
June 1, 2007
Last Updated
May 9, 2008
Record last verified: 2008-05