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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

Primary Purpose

Colorectal Neoplasms, Hepatocellular Carcinoma, Cholangiocarcinoma

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

oral nutritional supplement rich in eicosapentanoic acid

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring oral nutritional supplement, eicosapentanoic acid, gastroenterological tumors, muscle function, quality of life, body composition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 3 months missing or withdrawn consent simultaneous participation in another trial

Sites / Locations

Charite University Hospital

Outcomes

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)

Full Information

NCT ID

NCT00168987

First Posted

September 13, 2005

Last Updated

May 5, 2008

Sponsor

Charite University, Berlin, Germany

Collaborators

Pfrimmer Nutricia GmbH, Erlangen , Germany

1. Study Identification

Unique Protocol Identification Number

NCT00168987

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Pfrimmer Nutricia GmbH, Erlangen , Germany

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Hepatocellular Carcinoma, Cholangiocarcinoma

Keywords

oral nutritional supplement, eicosapentanoic acid, gastroenterological tumors, muscle function, quality of life, body composition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

oral nutritional supplement rich in eicosapentanoic acid

Primary Outcome Measure Information:

Title

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

Title

improvement of cognitive function at two months

Title

improvement of quality of life at two months

Secondary Outcome Measure Information:

Title

tolerance of the oral nutritional supplement

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthias Pirlich, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charite University Hospital

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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