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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168987
• Other study ID #: EA1/174/05
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 5, 2008
• Start date: January 2005
• Est. completion date: June 2007

Study information

• Verified date: May 2008
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Colorectal Neoplasms
• Hepatocellular Carcinoma

Intervention

Drug:
• oral nutritional supplement rich in eicosapentanoic acid

Locations

Country	Name	City	State
Germany	Charite University Hospital	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Pfrimmer Nutricia GmbH, Erlangen , Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of muscle function (hand grip strength, respiratory muscle function) at two months
Primary	improvement of cognitive function at two months
Primary	improvement of quality of life at two months
Secondary	tolerance of the oral nutritional supplement
Secondary	improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)