Parenteral Nutrition Support for Patients With Pancreatic Cancer

June 11, 2009 updated by: CONKO-Studiengruppe

Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Universitätsmedizin Berlin - Charité

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • prefinal status
  • septic disease

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: parenteral nutrition
25kcal/kg/bw /day via parenteral support
Dietary supplement: parenteral nutrition
25kcal/kg bw with parenteral nutrition
Other Names:
  • no specific brand name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
nutritional status presented by phase angle
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
quantity of port infections, quantity of oedema, quantity of diarrhea
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

CONKO-Studiengruppe

Collaborators

Fresenius AG

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

January 1, 2002

Primary Completion (ACTUAL)

January 1, 2004

Study Completion (ACTUAL)

May 1, 2004

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (ESTIMATE)

June 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2009

Last Update Submitted That Met QC Criteria

June 11, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C25.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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