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CompletedNCT00919659Updated Jun 12, 2009

Parenteral Nutrition Support for Patients With Pancreatic Cancer

A Phase 2 interventional study of parenteral nutrition in Cancer Cachexia and Pancreatic Cancer, sponsored by CONKO-Studiengruppe. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-12.

Sponsored by CONKO-Studiengruppe · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer Cachexia
  • Pancreatic Cancer

Keywords

  • parenteral nutrition
  • cancer cachexia
  • pancreatic cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 32 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

CONKO-Studiengruppe is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • prefinal status
  • septic disease
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    parenteral nutrition

    25kcal/kg/bw /day via parenteral support

    Dietary Supplement: parenteral nutrition

Interventions

  • Dietary supplementparenteral nutrition

    25kcal/kg bw with parenteral nutrition

    Also known as: no specific brand name

06

What researchers measure

Primary outcomes

  1. nutritional status presented by phase angle

    Time frame: 12 weeks

Secondary outcomes

  1. quantity of port infections, quantity of oedema, quantity of diarrhea

    Time frame: 12 weeks

07

Study locations

1 site
  • Universitätsmedizin Berlin - Charité
    Berlin, 13353, Germany
08

References and documents

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. PubMed 20214798 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00919659
Lead sponsor
CONKO-Studiengruppe
Collaborators
Fresenius AG
First posted
Jun 12, 2009
Start date
Jan 2002
Primary completion
Jan 2004
Completion
May 2004
Last update
Jun 12, 2009

Study contacts

helmut oettle, MD
principal investigator · CONKO-Studiengruppe

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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