Parenteral Nutrition Support for Patients With Pancreatic Cancer

NCT ID: NCT00919659

Last Updated: 2009-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-05-31

Brief Summary

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The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.

Detailed Description

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To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.

Conditions

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Cancer Cachexia Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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parenteral nutrition

25kcal/kg/bw /day via parenteral support

Group Type EXPERIMENTAL

parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

25kcal/kg bw with parenteral nutrition

Interventions

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parenteral nutrition

25kcal/kg bw with parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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no specific brand name

Eligibility Criteria

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Inclusion Criteria

* histological proved pancreatic cancer
* progressive cancer cachexia
* refractive to enteral supplementation
* informed consent

Exclusion Criteria

* prefinal status
* septic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius AG

INDUSTRY

Sponsor Role collaborator

CONKO-Studiengruppe

OTHER

Sponsor Role lead

Responsible Party

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Universitätsmedizin Berlin - Charité

Principal Investigators

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helmut oettle, MD

Role: PRINCIPAL_INVESTIGATOR

CONKO-Studiengruppe

Locations

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Universitätsmedizin Berlin - Charité

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Pelzer U, Arnold D, Govercin M, Stieler J, Doerken B, Riess H, Oettle H. Parenteral nutrition support for patients with pancreatic cancer. Results of a phase II study. BMC Cancer. 2010 Mar 9;10:86. doi: 10.1186/1471-2407-10-86.

Reference Type DERIVED
PMID: 20214798 (View on PubMed)

Other Identifiers

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C25.0

Identifier Type: -

Identifier Source: org_study_id

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