Influence of an Oral Nutritional Supplement Rich in Omega... | NCT00168987

Studies
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

NCT00168987

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

May 9, 2008Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Colorectal Neoplasms
Hepatocellular Carcinoma
Cholangiocarcinoma

Interventions

oral nutritional supplement rich in eicosapentanoic acid

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Nov 2006Actual

Completion Date

Jun 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2008

Last Update Posted Date

May 9, 2008Estimated

Name	Class
Pfrimmer Nutricia GmbH, Erlangen , Germany	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
oral nutritional supplement rich in eicosapentanoic acid	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
tolerance of the oral nutritional supplement
improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Pirlich, MD	Charite University Hospital, Dept. of Gastroenterology, Hepatology and Endocrinology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University Hospital		Berlin		10117	Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D006528	Carcinoma, Hepatocellular
D018281	Cholangiocarcinoma

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D008113	Liver Neoplasms
D008107	Liver Diseases

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D005395	Fish Oils
D009821	Oils