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Parenteral Nutrition Support for Patients With Pancreatic Cancer


2002-01


2004-01


2004-05


32

Study Overview

Parenteral Nutrition Support for Patients With Pancreatic Cancer

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.

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.

  • Cancer Cachexia
  • Pancreatic Cancer
  • DIETARY_SUPPLEMENT: parenteral nutrition
  • C25.0

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2009-06-09  

N/A  

2009-06-11  

2009-06-11  

N/A  

2009-06-12  

2009-06-12  

N/A  

2009-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care


Allocation:
Non Randomized


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: parenteral nutrition

25kcal/kg/bw /day via parenteral support

DIETARY_SUPPLEMENT: parenteral nutrition

  • 25kcal/kg bw with parenteral nutrition
Primary Outcome MeasuresMeasure DescriptionTime Frame
nutritional status presented by phase angle12 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
quantity of port infections, quantity of oedema, quantity of diarrhea12 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

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

  • Exclusion Criteria:

  • prefinal status
  • septic disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Fresenius AG

  • PRINCIPAL_INVESTIGATOR: helmut oettle, MD, CONKO-Studiengruppe

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.