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Parenteral Nutrition Support for Patients With Pancreatic Cancer

Primary Purpose

Cancer Cachexia, Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
parenteral nutrition
Sponsored by
CONKO-Studiengruppe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Cachexia focused on measuring parenteral nutrition, cancer cachexia, pancreatic cancer

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • prefinal status
  • septic disease

Sites / Locations

  • Universitätsmedizin Berlin - Charité

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

parenteral nutrition

Arm Description

25kcal/kg/bw /day via parenteral support

Outcomes

Primary Outcome Measures

nutritional status presented by phase angle

Secondary Outcome Measures

quantity of port infections, quantity of oedema, quantity of diarrhea

Full Information

First Posted
June 9, 2009
Last Updated
June 11, 2009
Sponsor
CONKO-Studiengruppe
Collaborators
Fresenius AG
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1. Study Identification

Unique Protocol Identification Number
NCT00919659
Brief Title
Parenteral Nutrition Support for Patients With Pancreatic Cancer
Official Title
Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CONKO-Studiengruppe
Collaborators
Fresenius AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Cachexia, Pancreatic Cancer
Keywords
parenteral nutrition, cancer cachexia, pancreatic cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
parenteral nutrition
Arm Type
Experimental
Arm Description
25kcal/kg/bw /day via parenteral support
Intervention Type
Dietary Supplement
Intervention Name(s)
parenteral nutrition
Other Intervention Name(s)
no specific brand name
Intervention Description
25kcal/kg bw with parenteral nutrition
Primary Outcome Measure Information:
Title
nutritional status presented by phase angle
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
quantity of port infections, quantity of oedema, quantity of diarrhea
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histological proved pancreatic cancer progressive cancer cachexia refractive to enteral supplementation informed consent Exclusion Criteria: prefinal status septic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
helmut oettle, MD
Organizational Affiliation
CONKO-Studiengruppe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsmedizin Berlin - Charité
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20214798
Citation
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.
Results Reference
derived

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Parenteral Nutrition Support for Patients With Pancreatic Cancer

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